Last Friday, AbbVie filed its Answer and Defenses to Amgen’s counterclaims of invalidity and noninfringement for each of the patents-in-suit. Of note, AbbVie stated that it lacked “sufficient knowledge and information to form a belief” regarding Amgen’s willingness to comply with the 180 notice of intent to market, a requirement that…
Last month, researchers published results from a randomized phase I clinical trial of CT-P10, a biosimilar candidate to rituximab, comparing the pharmacokinetics parameters and safety profiles in patients with rheumatoid arthritis in the Annals of the Rheumatic Diseases. The researchers reported that in the phase I trial CT-P10 and rituximab “demonstrated equivalent pharmacokinetic and comparable…
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…