The FDA approved Eli Lilly’s Lyumjev™ (insulin lispro-aabc injection, 100 units/mL and 200 units/mL) last month, which is a new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. The approval was based on two phase 3 clinical trials based on comparison of Lyumjev and Humalog (insulin lispro
FDA Approves First Biosimilars of 2020
As previously reported, the FDA had yet to approve any biosimilars in 2020 as of June 9, despite a growing pipeline. Since then, the FDA has approved two biosimilar products.
On June 11, Pfizer Inc. announced the FDA’s approval of Nyvepria™ (pegfilgrastim-apgf), a biosimilar of Amgen’s Neulasta™. Nyvepria is indicated “to decrease the incidence of…
Committee for Medicinal Products for Human Use Provides Biosimilar Updates at March Meeting
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) held its monthly meeting on March 23-26, 2020. During the meeting, the CHMP reported important updates on the status of the approval process for biosimilars relating to etanercept and rituximab.
- Nepexto® (Etanercept)
At the meeting, the CHMP adopted a positive opinion that recommended…
House Democrats Seek to Remove Biologics Exclusivity Period From USMCA
On July 11, 2019, more than 110 House Democrats wrote a letter to U.S. Trade Representative Robert E. Lighthizer expressing strong opposition to provisions in the United States-Mexico-Canada Agreement (USMCA) trade agreement, including the provision setting a minimum of 10 years of marketing exclusivity for biologic drugs.
As discussed here, in the United States,…
Eli Lilly Files PGR Petition against Genentech’s IL-17A/F Heterodimer Patent
On April 2, 2019, Eli Lilly and Company (“Lilly”) filed a Petition for Post-Grant Review (“PGR”) of Genentech’s U.S. Patent 10,011,654 (“the ’654 patent”). The ’654 patent, entitled “Antibodies Directed to IL-17A/IL-17F Heterodimers,” has just seven claims, with independent claim 1 drawn to “[a]n isolated humanized monoclonal antibody that binds to an IL-17A-17F heterodimer comprising…
Jury Finds Amgen Antibody Patents Not Invalid
Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for treatment of high cholesterol.[1] The case reached an important milestone recently as a jury entered a verdict largely upholding the validity of Amgen’s asserted patents, to the disappointment of Sanofi and Regeneron. A similar…
Biosimilars Will Get Special Names- Suffixes Are Here to Stay
On March 7, 2019, the U.S. Food & Drug Administration (FDA) released updated draft guidance announcing that it will create special names for biosimilar products to distinguish them from previously approved biologic products. Specifically, the guidance explains that:
- The FDA no longer intends to modify the proper names of biological products that have already been
…
Sandoz Files Declaratory Judgment of Non-Infringement For Filgrastim-Related Patent
On February 21, 2019, Sandoz Inc. (“Sandoz”) filed suit against Amgen Inc. and Amgen Manufacturing Limited (collectively “Amgen”) seeking declaratory judgment of non-infringement and invalidity of Amgen’s U.S. Patent No. 9,643,997 (“the ʼ997 patent”). The ʼ997 patent is directed to methods of purifying a protein expressed in a non-native limited solubility form in a non-mammalian…
PTAB Final Written Decision Finds All Claims (1-5) of U.S. Patent No. 8,821,873 Obvious Over the Combination of Five Prior Art References
As we previously reported, one of three Pfizer IPR petitions filed in April 2017 against Biogen-owned patents claiming methods of treatment with rituximab was instituted. The instituted IPR is IPR2017-01168 regarding U.S. Patent No. 8,821,873 (the “’873 patent”), and the PTAB recently issued its Final Written Decision.
Adhering to its institution decision where it…
USMCA Assailed as Exacerbating High Drug Prices
On November 5, 2018, twenty-nine organizations representing various groups including insurance companies, patient and consumer advocacy groups, unions, and retirees, submitted a letter to U.S. Trade Representative Robert Lighthizer to raise serious concerns that the recently renegotiated version of the North American Free Trade Agreement (NAFTA) – now proposed to be called the U.S.-Mexico-Canada Free…