In August, we reported that Coherus Biosciences, Inc. submitted an aBLA for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. Last week, Coherus announced that FDA has accepted its aBLA. Under the BPCIA, Coherus has 20 days from FDA acceptance to trigger the patent dance by providing the reference product sponsor (Amgen) with a…
Last week, Amgen filed a notice of appeal to the Federal Circuit from the district court’s judgment of non-infringement. The Federal Circuit has docketed the appeal as Case No. 17-1010. Amgen’s opening brief will be due in early December, absent any extensions of time or other delays in the appeal…
At yesterday’s European Society for Medical Oncology (ESMO) meeting, Merck Sharp & Dohme Corp. announced positive data from two studies regarding its Keytruda ® (pembrolizumab) biologic. According to Merck’s press release, Keytruda performed better than the standard of care chemotherapy as a first line therapy for patients with metastatic non-small…
As Congress pressures manufacturers to move biosimilars to market more quickly and the need for lower priced prescription drugs increases, there is a concern that public trust in the safety and efficacy of these new drugs could suffer. However, PharmExec.com reported that a Sanford C. Bernstein financial analyst was optimistic…
During the European Academy of Dermatology and Venereology Congress in Vienna, Johnson & Johnson presented data on their experimental psoriasis drug, guselkumab. Guselkumab targets a protein, interleukin-23, which is specifically involved with the skin’s immune responses. Guselkumab cleared or nearly cleared the skin of 81% of patients during a final-stage…
Teva Pharmaceutical Industries Ltd., Celltrion, Inc. and Celltrion Healthcare announced that the companies have entered into an exclusive partnership to commercialize two of Celltrion’s biosimilar candidates: CT-P10, a proposed mAb biosimilar to Rituxan (rituximab), and CT-P6, a proposed mAb biosimilar to Herceptin (trastuzumab). Stay tuned to the Big Molecule Watch…
Earlier this week, the United States Supreme Court denied Amphastar Pharmaceutical’s petition for certiorari regarding the scope of the safe-harbor of 35 U.S.C. § 271(e)(1), a provision that generic drug and biosimilar makers often rely upon to shield their manufacturing and testing activities from claims of patent infringement. The case…
As we reported in August, Samsung BioLogics, the biologic drug arm of Samsung Group was planning to raise USD$2.5 billion through an IPO. Yesterday Samsung BioLogics priced 16.5 million shares, valuing the company at as much as USD$8.2 billion. Whereas Samsung BioLogics is a contract manufacturer of biologic drugs, its…
Big Molecule Watch is here to keep you up to date with conferences near and far. Biosimilars Congress India 2016 will take place in Hyderabad, India from October 13-14th. Registration is open and you can even request the proposed agenda ahead of time. The 6th International Conference and Exhibition on…
Amgen has filed its answer in response to AbbVie’s complaint alleging infringement of 10 patents that allegedly cover Amgen’s recently-approved adalimumab biosimilar, Amjevita (formerly known as ABP501). Amgen asserts that AbbVie’s responses to its aBLA and required disclosures were deficient. Specifically, Amgen asserts that AbbVie did not provide an adequate…