Genentech filed a complaint last Friday in the District of Delaware against Pfizer for infringement of 40 patents under the BPCIA regarding PF-05280014, Pfizer’s biosimilar of Herceptin® (trastuzumab). According to the complaint, the FDA accepted Pfizer’s aBLA for review on August 21, 2017. Genentech’s complaint acknowledges that the parties had started, but not completed, the information exchanges of the…
We previously reported on Amgen’s complaint in the Central District of California seeking a declaratory judgment that 27 Genentech patents are not infringed by Genentech’s bevacizumab biosimilar (Mvasi®). On November 15, 2017, Genentech moved to dismiss the Amgen DJ action. Genentech argues that the court lacks jurisdiction over Amgen’s DJ action…
Samsung Bioepis announced today that the European Commission (EC) has granted marketing authorization for Ontruzant®, a biosimilar for Herceptin® (trastuzumab), across all 28 European Union member states and the European Economic Area member states of Norway, Iceland and Liechtenstein. According to the press release, Ontruzuant® is approved for the treatment of…
Here are some updates since our last IPR update: HUMIRA On November 6, 2017, Sandoz filed an IPR Petition challenging AbbVie’s U.S. Patent No. 9,187,559 (IPR2018-00156). The ‘559 patent is directed to a method for treating idiopathic inflammatory bowel disease. RITUXAN On November 6, 2017, the Board denied institution of an IPR on Pfizer’s…
On November 14, 2017, Sandoz announced data from four clinical trials comparing its proposed adalimumab and rituximab biosimilars to their reference drugs, Humira® and Rituxan®. We previously reported that the Sandoz adalimumab biosimilar is currently under EMA review. As we reported here, the Sandoz rituximab biosimilar has been approved by the European Commission…
Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all manufacturers of the same drug, which eliminates duplicative paperwork. This draft guidance is part of the FDA’s new two-pronged…
As we previously reported, yesterday the Federal Circuit affirmed the Southern District of Florida’s finding of non-infringement in Amgen v. Apotex. In that case, Amgen asserted the ’138 patent against Apotex based on Apotex’s aBLAs for biosimilar versions of Amgen’s Grastofil™ (filgrastim) and Lapelga™ (pegfilgrastim) products. Claim 1, the only independent claim,…
Boehringer Ingelheim (BI) announced today that it received marketing authorization in Europe for Cyltezo®, which is a biosimilar to Humira®. Cyltezo® was approved for the treatment of multiple chronic inflammatory diseases in adults and children. As previously reported, BI’s Cyltezo® was approved by the FDA on August 25, 2017, and…
As we previously reported, Amgen appealed the Southern District of Florida’s judgment of non-infringement in favor of Apotex in litigation regarding Apotex’s proposed filgrastim and pegfilgrastim biosimilars. Today the Federal Circuit issued a decision affirming the district court’s finding of non-infringement. We will post a summary of the opinion later today.
Below are regulatory and development updates regarding a number of biosimilar candidates. Today, Amgen and Allergen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 215, their proposed biosimilar of Avastin®…