Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are highly similar to existing biological products and are designed to be as effective and safe as the brand name drugs, offer the potential to provide
On September 27, 2022, Judge Richard Andrews of the District of Delaware granted Novartis’s motion to dismiss declaratory judgment (“DJ”) counterclaims raised by two generic drug manufacturers in the ongoing litigation regarding Novartis’s heart failure medication, Entresto® (sacubitril/valsartan).[1] The decision provides guidance to ANDA applicants seeking to maintain a case or controversy for DJ
On September 9, 2022, Biogen Inc. and Biogen MA Inc. (“Plaintiffs”) filed suit against Sandoz Inc., Sandoz International GMBH, Sandoz GMBH, and Polpharma Biologics S.A. (collectively, “Defendants”) in the District of Delaware concerning twenty-eight different patents. Although the complaint was filed under seal, the complaint appears to be related to Defendants’ natalizumab biosimilar (proprietary name
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a
Updated November 15, 2021
On October 15, 2021, the U.S. Food and Drug Administration (“FDA”) approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar to AbbVie’s blockbuster immunosuppressant Humira® (adalimumab). We previously discussed Boehringer Ingelheim’s Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics Price Competition and Innovation Act (“BPCIA”). The
The recently enacted “Purple Book Continuity Act of 2019” went into effect as of June 25, 2021. The FDA must proactively update the Purple Book information every 30 days with an alphabetical list of licensed biologics, including the date of marketing application approval and the marketing/licensure status. Additionally, there is now a potentially higher price
Updated March 8, 2021
On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics Price Competition and Innovation Act (“BPCIA”). The Citizen Petition is available on regulations.gov under docket number: FDA-2020-P-2247. Boehringer Ingelheim seeks an interpretation of “strength” to
In Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., No. 2019-2402 (Fed. Cir. Nov. 5, 2020), the Federal Circuit clarified the venue analysis of 28 U.S.C. § 1400(b), which controls venue for patent infringement cases. Section 1400(b) provides that an action for patent infringement may be brought in the judicial district where the