On January 28, 2021, Bio-Thera Solutions, Ltd., a biopharmaceutical company based in China, announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for BAT1706, a proposed biosimilar to bevacizumab, referencing Genentech’s Avastin®, but excluding indications under orphan drug exclusivity protection. The FDA has set November 27, 2021,
The COVID-19 relief and spending bill signed into law on December 27, 2020, includes a provision – Division BB, Title III, Subtitle C, Section 325[1] – that adds a new paragraph 9 to 42 U.S.C. §262(k) requiring the U.S. Food & Drug Administration (“FDA”) to provide more information to the public about patented biological
On November 18, 2020, companies Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the United States Food and Drug Administration (“FDA”) accepted for review the Biologics License Application for SB11, a proposed biosimilar referencing Genentech, Inc. product Lucentis® (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders, which are
Pharmaceutical companies Biocon Biologics and Mylan announced at the end of last month the U.S. launch of their long-acting insulin glargine product Semglee. Semglee was approved in June as an equivalent to Sanofi’s reference product insulin glargine, Lantus.
The companies are launching Semglee at a “65% discounted list price,” calling it the lowest wholesale acquisition
Pharmaceutical companies Teva Pharmaceutical Industries Ltd. and Alvotech announced on Wednesday, August 5, 2020, that they will be entering into an exclusive partnership for the commercialization of biosimilar products in the United States. This partnership aims to combine Teva’s long-standing commercial presence and extensive infrastructure in the U.S. market with Alvotech’s scientific experience and state-of-the-art
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
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
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.
At the meeting, the CHMP adopted a positive opinion that recommended
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,
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