Shanghai Henlius Biotech, Inc. (“Henlius”) announced this week that it has entered into a license and collaboration agreement with Eurofarma Laboratórios SA (“Eurofarma”), a Brazilian multinational biopharmaceutical company, for the development, manufacturing and commercialization of three biosimilar products in 16 Latin American countries. The three products are HANLIKANG® (rituximab), HANQUYOU®…
On March 22, British Columbia’s Ministry of Health announced that three new enoxaparin biosimilars, Valero Pharmaceuticals’ REDESCA, Juno Pharmaceuticals’ , and Sandoz’s INCLUNOX, would be covered by PharmaCare, the province’s public health plan. Enoxaparin is a blood thinner that is used for the prevention and treatment of blood clot disorders. …
Big Molecule Watch honors Women’s History Month by recognizing the women who have contributed to the advancement of biologics and biosimilars. We highlight one such individual, Rosalyn Yalow, who received a Nobel Prize for Physiology or Medicine in 1977 for her work on radioimmunoassay. Dr. Yalow, together with her research…
On Monday, Biocon Biologics Limited (Biocon) announced that it will acquire Viatris’ rights in biosimilars assets for up to $3.3 billion. Viatris and Biocon previously partnered to bring SEMGLEE to market in the U.S. SEMGLEE (insulin glargine-yfgn) injection launched last year in the U.S. as the first-ever interchangeable biosimilar approved…
Last week, Biogen Inc. announced it had reached an agreement to sell its equity stake in the Samsung Bioepis joint venture to partner Samsung Biologics for an aggregate consideration of up to $2.3 billion. According to a press release from Samsung Biologics, Biogen initially invested a 15% stake when the…
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at the Federal Circuit, at the PTAB, and even at the ITC. Biosimilars…
As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…
On November 8, 2021, Bio-Thera Solutions, Ltd. announced that China’s National Medical Products Administration has accepted the marketing authorization application for BAT1806, a biosimilar of Roche’s Actemra® (tocilizumab), which is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R). Actemra® has been approved in the United States for the…
In their respective third quarter financial results, Amgen and Pfizer both announced plans to seek interchangeable status for select biosimilars. Amgen announced that patients are currently being enrolled in Phase 3 studies to support interchangeability designation in the U.S. for biosimilars of AMJEVITA (adalimumab) and ABP 654 (ustekinumab). Pfizer also…
Last week, Coherus and Junshi Biosciences announced that the FDA accepted their BLA for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after…