Below are some highlights of recent news in biosimilar development: Earlier this week, Mylan and Revance Therapeutics, who are collaborating in developing a biosimilar of BOTOX (onabotulinumtoxinA), reported on their quarterly earnings calls that they participated in an initial advisory meeting with FDA at which the agency provided guidance on…
On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. The ’997 patent relates to a method of protein purification and is in the same patent family…
Following the Celltrion and Pfizer settlements of the trastuzumab litigation, the Federal Circuit granted the request of the Director of the PTO to intervene under 35 U.S.C. § 143 (i.e., defend a PTAB decision when a petitioner withdraws on appeal) in the Genentech appeals of final written decisions of unpatentability in Case…
Earlier this week, Sandoz announced the launch of its adalimumab biosimilar, HYRIMOZ, in 40-mg doses for subcutaneous injection in either a syringe or prefilled pen, in Spain. As we reported earlier, Sandoz previously launched HYRIMOZ in the UK in October 2018. Samsung Bioepsis and Mylan also launched adalimumab biosimilars in…
Last week, Health Canada announced that biologic drugs, including biosimilars, will be identified “by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix. Both the brand name and non-proprietary name should be used throughout the medication use process so that biologics that share the…
Pfizer announced today that the European Commission has approved its Avastin® (bevacizumab) biosimilar ZIRABEV™ for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma…
Yesterday, the PTAB issued final written decisions in two IPR proceedings (IPR2017-01884 and IPR2017-01879) it instituted on February 15, 2018 against U.S. Patent No. 8,679,487 (the ’487 patent), held by Immunex. The ’487 patent is directed to isolated human antibodies that compete with a reference antibody for binding to human interleukin-4 (IL-4) receptor. …
On February 5, 2019, Mundipharma announced the European launch of Pelmeg® (pegfilgrastim), a biosimilar of Neulasta®. As we have previously reported, Mundipharma acquired Pelmeg® from Cinfa Biotech and it was approved by the European Commission in November 2018. According to the press release, Pelmeg® is now available in Germany, the…
On Monday, Magistrate Judge Lloret, who is visiting the U.S. District Court for the District of Delaware from the Eastern District of Pennsylvania, granted Boehringer Ingelheims’s (“BI’s”) motion to compel discovery relating to its unclean hands defense in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning BI’s aBLA for a biosimilar version of AbbVie’s…
On January 18, 2019, in Amgen v. Sanofi, the ongoing litigation concerning Sanofi and Regeneron’s Praluent® (alirocumab) product, Judge Andrews of the District of Delaware denied Sanofi’s motion for summary judgment that the asserted genus claims directed to monoclonal antibodies that inhibit PCSK9 (such as Amgen’s Repatha® and Sanofi/Regeneron’s Praluent® products)…