Samsung Bioepis announced that it has entered into a Strategic Collaboration Agreement with Takeda Pharmaceutical Company to co-develop novel biologic therapies in unmet disease areas. The companies’ first therapeutic candidate is intended to treat severe acute pancreatitis. According to the press release, diversifying into novel biologics development represents “a new chapter” for…
Ireland’s Department of Health (the “Department”) recently reported on its website that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.” The Department is now asking the public for its views regarding the…
As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (Pegfilgrastim) and Ogivri (Trastuzumab), and have filed applications for marketing authorization in the European Union (EU) for those products. We also posted here that in July 2017, the French National Agency for Medicines and Health…
As we have previously reported, on July 25th, Coherus filed a motion to stay discovery pending the result of its motion to dismiss in its litigation against Amgen regarding pegfilgrastim, and Amgen filed an opposition on August 8th . Yesterday, Coherus filed its reply. In reply, Coherus argued that Amgen’s…
On August 8, Sanofi-Aventis filed a complaint for patent infringement against Merck Sharp & Dohme in the U.S. District Court for the District of New Jersey regarding Merck’s proposed follow-on biologics of Sanofi-Aventis’s Lantus® and Lantus® SoloSTAR® ([rDNA origin] insulin glargine) subcutaneous injection vial products. The complaint alleges infringement of two patents: U.S….
Coherus Biosciences filed a petition at the US Patent and Trademark Office last week, seeking to cancel the claims of U.S. Patent 8,163,522 (the ’522 patent), entitled “Human TNF Receptor,” and assigned on its face to Hoffman-LaRoche Inc. According to a Coherus press release, the ’522 patent is controlled by…
Mazumdar-Shaw, Chairman & Managing Director of Biocon, recently stated that Biocon is developing a portfolio of 10 biosimilars, and will continue to invest 12-15% of its revenue in research and development. According to Ms. Mazumdar-Shaw, Biocon’s biosimilars span insulin, monoclonal antibodies, and other recombinant proteins for markets in India and…
Today, the Federal Circuit dismissed Amgen’s appeal from and mandamus petition regarding the U.S. District Court for the Delaware’s order denying Amgen’s motion to compel discovery for lack of jurisdiction under the collateral order doctrine. Amgen sought to compel discovery from Hospira regarding two patents that Amgen had not included in its…
On July 31, Express Scripts identified new formulary exclusions that will go into effect on January 1, 2018. For example, Amgen’s rG-CSF product, NEUPOGEN, will be excluded in favor of Teva’s rG-CSF product, GRANIX, and Sandoz’s biosimilar, ZARXIO. Express Scripts has not explained, however, what the reimbursement level will be…
Coherus announced completion of initial phases of the Biologic Price Competition and Innovation Act patent exchange with Amgen for its pegfilgrastim biosimilar candidate CHS-1701. Coherus reported that it has received a complete response letter from FDA for CHS-1701’s biologic license application (BLA) and it anticipates resubmitting the BLA in the…