Coherus Biosciences, Inc. (“Coherus”) has filed four petitions with the Patent Trial and Appeal Board (“PTAB”) for inter partes review (“IPR”) of U.S. Patent No. 9,085,619 (“the ’619 patent”) related to AbbVie’s Humira® (adalimumab).  The challenged claims of the ’619 patent are directed to formulations of adalimumab and closely-related antibodies.  Adalimumab is a TNF (tumor necrosis factor) inhibitor that binds to TNF-alpha (TNF-α) preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Humira® is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

The proceedings are IPR2017-00822; IPR2017-00823; IPR 2017-00826; and IPR2017-00827. The only real party-in-interest identified for Petitioner is Coherus BioSciences Inc.  The real parties-in-interest identified for the Patent Owner are AbbVie Biotechnology Ltd. and AbbVie Inc.

In addition to the four petitions filed by Coherus for the ’619 patent, several other IPRs have been instituted by the PTAB on other patents related to Humira®.  A complete list of IPRs can be found in RFEM’s IPR Dashboard.

We will continue to provide updates as these cases progress.

Hospira, Inc. (“Hospira”) filed two additional new petitions with the Patent Trial and Appeal Board (“PTAB”) on January 30, 2017 for inter partes review (“IPR”) of U.S. Patent Nos. 6,627,196 (“the ’196 patent”) and 7,371,379 (“the ’379 patent”) related to Genentech’s Herceptin® (trastuzumab).  These filings come on the heels of three petitions Hospira filed earlier in January 2017 as discussed here. The challenged claims of the ’196 and ’379 patents are generally directed to methods of treating cancers characterized by the overexpression of ErbB2 by administering an effective amount of an anti-ErbB2 antibody using a dosage regimen that provides a large initial dose, followed by the subsequent administration of additional dosages in amounts that are the same as or less than the initial dosage spaced two to three weeks apart (referred to in the specification as “front loading”).

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor (HER2)/neu. Herceptin® is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.

The proceedings are IPR2017-00804 (involving the ’196 patent) and IPR2017-00805 (involving the ’379 patent). As in the earlier filed petitions, the real party-in-interest identified for Petitioner is Hospira, Inc. Petitioner also identified Pfizer, Inc. as a real party-in-interest who, going forward, may have control or an interest in the outcome of the proceeding. Here again, the only real party-in-interest identified by the Patent Owner is Genentech, Inc.

With the filing of these most recent petitions, Hospira has filed a total of six IPR petitions related to Herceptin® (trastuzumab).  Mylan has also filed a petition regarding Herceptin® (trastuzumab).  The PTAB has not yet issues a decision on institution in any of the proceedings.  A complete list of IPRs can be found in RFEM’s IPR Dashboard.

We will continue to provide updates as these cases progress.

The Supreme Court has agreed to hear its first biosimilar case interpreting two provisions of the Biologics Price Competition and Innovation Act (“BPCIA”).  On January 13, 2017, the Supreme Court granted Sandoz’s petition for certiorari in Sandoz, Inc. v. Amgen, Inc., et al. No. Case No. 2015-1039 and on Amgen’s conditional cross-petition for certiorari in Amgen Inc., et al. v. Sandoz, Inc., Case No. 2015-1195.  The consolidated cases raise two critical issues related to the patent dispute resolution provisions of BPCIA. This is the first time the Supreme Court has accepted an opportunity to consider and interpret the BPCIA statutory scheme. The issues before the Supreme Court are central to the applicability of the statute and arose between Amgen and Sandoz in conjunction with Sandoz’s filing of an abbreviated biologics license application for filgrastim (a proposed biosimilar to Amgen’s Neupogen®) and pegfilgrastim (a proposed biosimilar to Amgen’s Neulasta®).

Issues to Be Decided

The issues the Supreme Court will decide in the appeal of Amgen v. Sandoz are: (1) whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide the reference product sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the applicant “shall provide;” and (2) whether, where an applicant fails to provide that required information, the sponsor’s sole recourse is to commence a declaratory judgment under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii).

The issues that the Supreme Court will decide in the appeal of Sandoz v. Amgen are: (1)  whether notice of commercial marketing given before Food and Drug Administration approval can be effective; and (2) whether, in any event, it is improper to treat Section 262(l)(8)(A) – the Biologics Price Competition and Innovation Act of 2009’s “Notice of commercial marketing” provision which states that a biosimilar applicant shall provide notice to the incumbent seller of the biological product “not later than 180 days before the date of the first commercial marketing of the biological product licensed under” an abbreviated pathway for biosimilars – as a stand-alone requirement and as creating an injunctive remedy that delays all biosimilars by 180 days after approval.

Factual Background

The BPCIA established an abbreviated approval pathway allowing applicants seeking approval of biologics to rely on certain clinical data contained in an earlier application submitted by the reference product sponsor if they can demonstrate that product is “biosimilar” to the previously approved reference product. The BPCIA amended the Patent Act to create an artificial “act of infringement” based on the filing of a biosimilar application.  See 35 U.S.C. § 271(e)(2)(C), (e)(4), (e)(6). The BPCIA further provides a series of steps for the exchange of patent information and the potential for early resolution of patent infringement claims related to the product that is the subject of the application. See 42 U.S.C. 262(l).  This process is commonly referred to as the “patent dance.”

Pertinent to the issues presented here, section § 262(l)(2)(A) of the BPCIA states that, upon FDA acceptance of an application for review, the applicant “shall provide” the reference sponsor with a copy of its application and other information describing the manufacturing processes for the biosimilar product.  See 42 U.S.C. § 262(l)(2)(A).  Separately, the BPCIA provides that, under § 262(l)(8)(A), an applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).”

Amgen markets filgrastim under the brand name Neupogen®. In May 2014, Sandoz submitted an abbreviated biologics license application seeking FDA approval of its proposed biosimilar filgrastim product. In July 2014, Sandoz informed Amgen of its filing and of its intent to launch the product immediately once it received FDA approval. Subsequently, upon FDA’s acceptance of its application, Sandoz informed Amgen that it had decided not to disclose a copy of its application or manufacturing information to Amgen and advised Amgen that it was entitled to sue Sandoz under § 262(l)(9)(C) for declaratory judgment of patent infringement, validity, and enforceability. Paragraph 9(C) provides that if an applicant does not provide the application and information as required under (2)(A), “the reference product sponsor, but not the subsection (k) applicant may bring an action under section 2201 of title 28, United States Code, for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.”

The FDA approved Sandoz’s product in March 2015 and Sandoz again gave Amgen notice of its intent to commercially market its product. Amgen subsequently filed suit alleging that Sandoz violated the BPCIA by failing to provide Amgen with a copy of its application and by giving ineffective notice of commercial marketing. Ruling on the parties’ cross-motions for judgment on the pleadings, the district court concluded that the plain language and statutory scheme of the BPCIA render Sandoz’s decision not to disclose its application permissible and that such a decision does not provide the reference sponsor a basis for injunctive relief. The district court further concluded that an applicant may give 180-day notice of commercial marketing to a sponsor prior to obtaining FDA approval.

The Federal Circuit Decision

On appeal, the Federal Circuit concluded that the while the language “shall provide” in section (l)(2)(A) would appear to create a mandatory requirement that an applicant disclose its application and manufacturing information to the reference sponsor when read in isolation, the provision cannot be read in isolation. The Court recognized that other portions of the BPCIA explicitly contemplate that an applicant may fail to disclose the required information by the statutory deadline and specifically provide the consequence of such a failure is the exposure to an infringement action under 42 U.S.C. § 262(l)(9)(C) and 35 U.S.C. § 271(e)(2)(C)(ii). The Court further concluded that (l)(9)(C) and § 271(e) provide the only remedies available to a reference product sponsor under the circumstances because “the BPCIA has no other provision that grants a procedural right to compel compliance with the disclosure requirement of paragraph (l)(2)(A).” Thus, according to the Federal Circuit, by taking actions specifically addressed by the BPCIA, Sandoz did not violate the statute.   The effect of this decision is that a section (k) applicant may “opt out” of the disclosure requirements of the patent dance.

The Federal Circuit, however, agreed with Amgen that notice of commercial marketing is only effective for a “licensed” product, meaning that the notice must be provided after the product is approved (licensed) by the FDA.  The Court reasoned that providing notice only after approval of a license allows the reference sponsor to definitively determine the patents involved and the scope of injunctive relief to seek. The Court ultimately held that Sandoz’s initial notice was ineffective, but that its notice subsequent to its approval was effective. The Court further concluded that notice of commercial marketing is an independent mandatory requirement that is not excused if the applicant chooses not to disclose its application and participate in the patent dance.

The Supreme Court’s decision to hear the cases was surprising to some because the Court previously denied the petition for certiorari in Apotex v. Amgen, another case involving the notice of commercial marketing requirement.  After Amgen v. Sandoz had been decided, the Federal Circuit issued another decision, a year later, reiterating the principles of its earlier decision – namely that the notice of commercial marketing required by 42 U.S.C. § 262(l)(8)(A) must occur post-licensure. The issue in Apotex v. Amgen was whether the commercial notice requirement of section (8)(A) was also necessary post-licensure if the applicant had elected to provide access to its application pursuant to section (2)(A) of the BPCIA rather than “opting out” of the patent dance.

Unlike Sandoz, Apotex had elected to participate in the patent dance and provided Amgen with a copy of its application and information regarding its manufacturing process for its biosimilar product within 20 days of the FDA’s acceptance of its application pursuant to section (l)(2)(A) of the BPCIA.  During the exchange of information, Apotex sent a letter to Amgen providing notice of its future intent to commercially market its product, prior to receiving approval from FDA for its product. Following the required negotiations, the parties agreed to an infringement action on two patents and Amgen subsequently filed suit on August 6, 2015. In October 2015, Amgen filed a motion for a preliminary injunction requesting the district court require Apotex to provide the notice of commercial marketing pursuant to section (8)(A) once receiving a license (i.e. upon product approval), and confirming that commercial marketing would not begin until 180 days following that notice. The district court granted the motion and Apotex appealed.

The Federal Circuit affirmed the district court’s ruling, stating that the fact that “Apotex gave (2)(A) notice provides only a factual distinction, not a legally material distinction, between its situation and that of Sandoz in Amgen v. Sandoz.” The Court concluded that the (8)(A) post-licensure notice requirement is mandatory and enforceable by an injunction regardless of whether disclosure under (2)(A) has been provided. The Court also rejected Apotex’s contention that § 262(l)(9)(B) makes a declaratory-judgment suit the exclusive remedy for violation of the commercial notice requirement of section (8)(A). Amgen filed a petition for writ of certiorari but the Supreme Court denied the petition in that case.

On January 25, 2017, the Supreme Court issued a briefing schedule.  According to the schedule, Sandoz’s opening brief in 15-0139 is due February 10, 2017, Amgen’s consolidated opening brief in 15-1195 and response in 15-039 is due on March 10, 2017, Sandoz’s consolidated reply in 15-0139 and response in 15-1195 is due March 31, 2017, and Amgen’s reply in 15-1195 is due on April 14, 2017.  Amici briefs in support of Sandoz or in support of neither party are due February 17, 2017.  Amici briefs in support of Amgen are due March 17, 2017.

Hospira, Inc. (“Hospira”) filed three petitions with the Patent Trial and Appeal Board (“PTAB”) on January 20, 2017 for inter partes review (“IPR”) of U.S. Patent Nos. 7,846,441 (“the ’441 patent”) and 7,892,549 (“the ’549 patent”) related to Genentech’s Herceptin® (trastuzumab).  The challenged claims of the ’441 patent are directed to a method of treating cancers linked to the overexpression of the human ErbB2 protein by administering an anti-ErbB2 antibody that binds to epitope 4D5 and a taxoid chemotherapeutic agent in the absence of an anthracycline derivative.  The challenged claims of the ’549 patent are directed to a method of treating cancers characterized by the overexpression of ErbB2 by administering a combination of an anti-ErbB2 antibody, a taxoid chemotherapeutic agent, and another therapeutic agent which may be another antibody, a growth inhibitory agent, or a cytokine.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor (HER2)/neu. Herceptin® is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.

The proceedings are IPR2017-00731 (involving the ’441 patent), IPR2017-00737 (involving the ’549 patent) and IRP2017-00739 (also involving the ’549 patent). The real party-in-interest identified for Petitioner is Hospira, Inc. Petitioner also identified Pfizer, Inc. as a real party-in-interest who, going forward, may have control or an interest in the outcome of the proceeding. The only real party-in-interest identified by the Patent Owner is Genentech, Inc.

This is not the first petition for IPR filed by Hospira regarding trastuzumab.  In September 2016, Hospira filed a petition for IPR on U.S. Patent No. 7,807,799.  Mylan has also filed a petition regarding Herceptin® (trastuzumab).  The PTAB has not yet issued a decision on institution in any of these proceedings.  A complete list of IPRs can be found in RFEM’s IPR Dashboard.

We will continue to provide updates as these cases progress.

Introduction

The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological products shown to be “highly similar” to already FDA-approved biological products.  By permitting the sponsor of a biological product to rely on data submitted by the holder of an FDA-approved biological product, the BPCIA is somewhat similar in concept to the abbreviated approval pathway for small molecule pharmaceuticals, commonly referred to as the Hatch-Waxman Act.  Just as there are important differences in biologics and small molecule pharmaceuticals, there are also important differences in the approval pathway of biologics under the BPCIA and the ANDA approval pathway of small molecule pharmaceuticals under Hatch-Waxman.

One important distinction between the two approval pathways in that under the BPCIA there are two different biological product classifications — those products that are “biosimilar” and those that are “interchangeable” to the reference drug product. As defined by the BPCIA, a “biosimilar” product is one in which “the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components,” and “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”  42 U.S.C. §262(i)(2).  In contrast, an “interchangeable” product is one in which “the biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.”  42 U.S.C. §262(i)(3).

The difference between the two classifications is significant because current federal law does not permit a pharmacist to simply substitute a biosimilar product with the reference product.  Therefore, in order for a patient to receive a biosimilar product, a medical professional must actually prescribe the biosimilar product in place of the reference product.  That is not the case, however, if the biological product is classified as “interchangeable.”  Indeed, a pharmacist may freely substitute the interchangeable biological product for the reference product, absent express direction to the contrary.  Accordingly, the “interchangeable” classification for a biological product provides an enormous competitive advantage to any sponsor that is able to meet the standard.  In that regard, it is of note that of the four biosimilar products that have been approved in the United States by FDA, none has been classified as interchangeable.

To understand why no biologics have yet been classified as “interchangeable” to the reference product, it is helpful to understand why there are two classifications of biological products in the first place.  The answer has to do with the inherent complexity of biological products.  Unlike a small molecule “generic” pharmaceutical, the structure of a biological product may differ somewhat from the structure of the reference product.  Such differences may arise for a number of reasons, e.g., an amino acid substitution in the primary amino acid sequence, or because of the particular expression system used to produce the protein.  Although the FDA recognizes that differences between a biological product and the reference product may not adversely affect the safety or efficacy of the biological product (as evidenced by the approval of four biosimilar products to date), it remains leery of permitting wholesale substitution of the reference product with the biological product absent a more thorough vetting process.   However, the industry remained in the dark regarding the details of that vetting process until recently when the FDA released its “Draft Guidance – Considerations in Demonstrating Interchangeability with a Reference Product” (“Interchangeability Guidance”) on January 17, 2017.

Statutory Requirements for Interchangeability

The Interchangeability Guidance set forth the FDA’s current thinking on the scientific criteria it expects a sponsor seeking approval for an interchangeable biological product to meet.  The Interchangeability Guidance explains that under the statute three conditions must be met: (1) the biological product must be biosimilar, (2) it must produce the same clinical result as the reference product in a patient, and (3) if the biological product is administered more than once, it must be shown that the risk of switching between the biological product and the reference product must not be greater than if the reference product was used without such switching.

“Biosimilarity”

With respect to the biosimilarity requirement, the FDA acknowledges that if the biological product had previously been approved as a biosimilar, then that same data may be used to satisfy the “biosimilarity” statutory criteria.  However, such data may not be sufficient to satisfy the “same clinical result” or the “risk of switching” criteria.

“Same Clinical Result”

The Interchangeability Guidance indicates that for a biological product to be approved as interchangeable, FDA expects to see data sufficient to show that the proposed biological product provides the “same clinical result” in all of the reference product’s licensed conditions for use.  This is important because the FDA has previously explained that a biosimilar product applicant is free to seek approval for less than all of the indications for which the reference product has been approved.  See Draft Guidance – Labeling for Biosimilar Products at §IV (March 2016).  Thus, although a sponsor may submit an application seeking approval for less than all of a reference product’s approved indications, it will not be possible for the sponsor’s product to be deemed interchangeable for the reference product without providing data effectively proving that it could be approved for all indications.  The result is that additional clinical studies may be required to show that a proposed biological product produces a “highly similar” clinical result in treating a disorder for which the applicant ultimately has no interest in pursuing approval.

“Risk of Switching”

The third criteria that must be met for interchangeability under the statue is that “risk of switching” for the proposed biological product must be shown to be no greater than the risk associated with using the reference product alone.  The Interchangeability Guidelines explain that  the “FDA expects that applications generally will include data from a switching study or studies,” and goes into some detail as to the relevant design considerations, including appropriate study endpoints, study populations, analysis, etc.

In terms of the study design, the FDA suggests either a dedicated switching study or an integrated study.   The dedicated study is one that only examines the effect of switching between the reference and proposed product.  In contrast, the integrated study is intended to be a single study that the sponsor will use to support a finding of no clinically meaningful differences between the proposed and reference products (i.e., for purposes of biosimilarity) and that evaluates the impact of switching between the reference product and the proposed product (i.e., for purposes of interchangeability).  In either case, the switching arm of the study will be expected to incorporate at least three switches with each switch crossing over to the alternate product.

If the reference product has been approved for multiple indications, the FDA recommends selecting an indication that “would be adequately sensitive” to evaluate the risk associated with switching between products for other indications.  Presumably, a sponsor would actively seek consultation with the FDA prior to proceeding with such a study to ensure the FDA agrees the selected indication is “adequately sensitive.”   Regardless, the sponsor will then have to provide scientific justification explaining how the data it has collected may be extrapolated to justify the interchangeability classification for other indications which were not expressly tested in a switching study.

The Influence of Patents on Interchangeability

Given the FDA’s interpretation that the statute requires a sponsor show the same clinical result is achieved for all approved indications, as well as potential difficulties in extrapolating data from a switching study looking at one indication to another, unexamined indication, one may wonder why a sponsor would ever seek approval for less than all of the approved indications.  In other words, why would a sponsor conduct all of that work and then voluntarily drop an indication that the data otherwise supports?  Although there may be several potential reasons, the patent landscape may provide the most significant answer to that question.

Imagine a scenario where a reference product has been approved for two distinct indications that are each covered by a different patent family.  A sponsor may be confident of its non-infringement and/or invalidity defenses for the patent(s) covering one indication, but less so in its defenses for patents covering the other.  Thus, the sponsor could reasonably make the decision to pursue approval for one indication, and design appropriate studies to show that its proposed biological product produces the same clinical result as the reference product for only that single indication.  However, in view of the new Interchangeability Guidelines, in making that decision, the sponsor will apparently forego any chance of FDA approval of its proposed product as interchangeable, as well as the financial gains that such a status confers.

This situation creates an interesting dilemma for the sponsor.  Should one go through the time and expense required to demonstrate the same clinical result is achieved for both indications (even though one will only seek approval for a single indication) in an attempt to be approved as an interchangeable product?  Or should one defer the cost of those studies until such time as the patent landscape is more favorable, and seek only approval as a biosimilar in the interim?  And those are only two of the myriad of considerations that a sponsor will have to face when wrestling with the decision of whether and how to pursue the interchangeable classification when faced with a potentially unfavorable patent landscape. It will be interesting to find out how the various stakeholders resolve this dilemma in the coming years.

You can read the full guidance here.

On January 12, 2017, FDA released its long-awaited final guidance on naming of biologics and biosimilars, entitled “Nonproprietary Naming of Biological Products.”  According to FDA, the nonproprietary naming convention provided in the final guidance is intended to aid pharmacovigilance and to help prevent confusion and inadvertent substitution.

FDA’s newly-issued guidance covers the nonproprietary naming convention for originator biological products, related biological products, and biosimilar products.  These products may have both a proprietary name established by the manufacturer (usually a trademark) and a non-proprietary (referred to by FDA as the “proper”) name.  The proper name of a biologic is different from its proprietary name and reflects scientific characteristics of the product, e.g., chemical structure and pharmacological properties.  FDA’s guidance document explains that “the proper name of a biological product helps health care providers identify the product’s drug substance and distinguish biological products from one another.”

Under the naming convention provided in the final guidance, “the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix.”

For originator biological products, FDA intends to use the name adopted by the USAN Council for the relevant biological substance as the core name when available.  For related biological products and biosimilar products, the proper name will contain a combination of the core name, which is the same as that of the previously-licensed product, followed by a unique, lowercase, four-letter suffix designated by FDA and attached to the core name via hyphen.  The guidance indicates that the proper name of interchangeable products will also use the same core name as the innovator product followed by a suffix, but FDA is still considering the appropriate suffix to be used for products designated as interchangeable.

The final guidance came more than a year after FDA first published a draft guidance on naming biologics in August 2015.  In the draft guidance, FDA specifically asked for comments on the potential benefits and challenges of designating a suffix that is meaningful versus a suffix that is devoid of meaning.  See “Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability” Notice, 80 Fed. Reg. 52296 (Aug. 28, 2015).  Industry response was mixed.  Prior to issuance of the draft guidance, in September 2013, GPhA filed a Citizen’s Petition and submitted a letter to FDA signed by 32 organizations recommending that all biosimilars share the same international non-proprietary name as the biologic reference product.  In November 2015, the Biosimilars Forum submitted comments in which it did not take a position on whether a suffix should be included in the U.S. proper name.  However, in the event FDA elects to include a suffix, then the organization urged that the suffix should be affixed to all biological products developed by a particular company and should be meaningful, as opposed to random, preferably derived from the company name.  In 2016, BIO and PhRMA submitted comments on the draft guidance and also jointly filed a Citizen’s Petition in favor of using a meaningful, distinguishing suffix.  

FDA decided to require a distinguishing suffix, but declined to adopt a convention that attaches any significance or meaning.  In particular, the final guidance provides that for all biological products, related biological products, and biosimilar products, the suffix should be “devoid of meaning.”  

Interestingly, FDA intends to apply the naming convention retroactively to previously-licensed biological products as well as prospectively to newly-licensed products.  For prospectively licensed products, FDA expects the applicant to propose up to 10 distinguishing suffixes, in the applicant’s order of preference, as part of the IND or BLA at the time of submission.  FDA has provided specific factors for guidance in selecting proposed suffixes and recommends the applicant include any supporting analyses for FDA’s consideration based on those factors.

FDA is still considering the process for implementation of the naming convention to previously-licensed biological products.  However, the guidance conveys that FDA intends for previously-licensed originator products, related biological products, and biosimilar products to receive a revised proper name with the product’s original proper name as the core and a distinguishing suffix added with a hyphen.  FDA expects to assign distinguishing suffixes for a limited number of previously-approved licensed products and provides guidance to the holders of pending applications and previously-approved products for submitting proposed suffixes as a prior-approved labeling supplement.  FDA may continue to use a prefix (along with a core name and a suffix) in some instances to distinguish related biologics from previously-licensed biological products (e.g., ado-trastuzumab emtansine-xxxx to distinguish over trastuzumab-xxxx).

The guidelines provide that the proposed suffix should be:

  • unique
  • devoid of meaning
  • four lowercase letters of which at least three are distinct
  • nonproprietary
  • attached to the core name with a hyphen
  • free of legal barriers that would restrict its usage

The guidelines further provide that the proposed suffix should not:

  • be false or misleading, such as by making misrepresentations with respect to safety or efficacy
  • include numerals and other symbols aside from the hyphen attaching the suffix to the core name
  • include abbreviations commonly used in clinical practice in a manner that may lead the suffix to be misinterpreted as another element on the prescription or order
  • contain or suggest any drug substance name or core name
  • look similar to or be capable of being mistaken for the name of a currently marketed product (e.g., should not increase the risk of confusion or medical errors with the product and/or other products in the clinical setting)
  • look similar to or otherwise connote the name of the license holder
  • be too similar to any other FDA-designated nonproprietary name suffix

Further, FDA encourages applicants to conduct due diligence on proposed suffixes to avoid any other prohibitions or restriction on use.  The final determination regarding acceptability of a proposed suffix will be based on FDA’s review of any information submitted by the sponsor and all information and analyses described in the guidance.

You can read the full Guidance document here.