The Biosimilars Forum applauded today’s proposed HHS rule attacking negotiated rebates between manufacturers and insurers.
Recently, a large biopharma company was forced to pay a $100M fee to their partner after halting commercialization of a biosimilar. Three years after they started the commercialization project, the company cited the cost of manufacturing the drug as too high and its projected selling price too low to justify bringing it to market.
As Congress begins to examine high prescription drug prices, the Pharmaceutical Care Management Association (PCMA) sent letters to several congressional committees highlighting the value pharmacy benefit managers (PBMs) provide to patients and payers as well as outlining policy options to reduce prescription drug costs.
Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune and other major diseases, announced today that the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for a biosimilar product candidate of bevacizumab (Avastin®).
Coherus BioSciences, Inc. (Nasdaq: CHRS), a commercial biosimilar company, today announced it has filed suit against Amgen in the United States District Court (Delaware) alleging that Amgen’s Humira® biosimilar, Amgevita™, infringes Coherus’ U.S. patents 10,155,039; 10,159,732; and 10,159,733. Each of the asserted Coherus patents is directed to stable formulations of adalimumab.
Coherus BioSciences, Inc.(Nasdaq: CHRS), a commercial biosimilar company, today announced it has executed settlement agreements with AbbVie Inc. that grant Coherus global, non-exclusive license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab (HUMIRA®) biosimilar.
Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced positive top-line results from a Phase 1/ Phase 3 study evaluating the pharmacokinetics, efficacy and safety of biosimilar candidate ABP 798, a biosimilar candidate to RITUXAN® (rituximab), compared to rituximab in patients with moderate-to-severe rheumatoid arthritis.
Bio-Thera Solutions, a clinical-stage pharmaceutical company, recently announced that dosing has begun in a Phase III clinical study for its tocilizumab biosimilar, BAT1806. Bio-Thera’s Phase III clinical trial will compare the safety and efficacy of BAT1806 and the reference product, Genentech’s RoActemra in patients with rheumatoid arthritis (RA).
Alvotech announced recently that it has successfully raised US$300M through a private bond offering. Net proceeds from the capital raised will be used to fuel continued growth, refinance of existing debt and the further development of Alvotech’s biosimilar assets.
The Center for Biosimilars, an online resource for emerging therapies that focuses on improving patient outcomes, interviewed Michael Kolodziej, M.D., vice president and chief innovation officer at ADVI Health Inc., about what payers will consider when developing strategies around biosimilars.
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