During the period leading up to the holidays, a number of biosimilar developers announced updates regarding their biosimilar pipelines. On December 5, Pfizer notified the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) of its wish to withdraw its application for marketing authorization for Fyzoclad (adalimumab), due to…
Here are our picks for the top-five most significant foreign biosimilar market developments in 2018: 1. Shake-up In Europe’s Adalimumab Market As a result of litigation and resulting global settlements, several adalimumab biosimilars launched in Europe this year. In October 2018, Amgen, Sandoz, Samsung Bioepis and Mylan launched adalimumab biosimilars,…
Here are our picks for the top-five most significant U.S. biosimilar market developments in 2018: 1. 2018 Sets New Records for Biosimilar Approvals and Launches When 2018 began, nine biosimilars had received FDA approval, and only three were on the U.S. market. This past year saw a record-breaking seven FDA…
As we have reported, over the course of the past thirteen months Plaintiffs Genentech, Inc. and City of Hope sued each of Pfizer, Celltrion and Teva, Amgen and Samsung Bioepis in the District of Delaware for patent infringement under the BPCIA based on their submissions of aBLAs seeking FDA approval…
Today, AbbVie and Pfizer announced that they reached a global resolution of all intellectual property-related litigation concerning Pfizer’s proposed biosimilar adalimumab. According to the press releases, AbbVie has granted Pfizer a non-exclusive license to AbbVie’s intellectual property relating to adalimumab in the United States and other countries. All litigation pending between the parties…
Following the FDA’s approval of Retacrit® (epotein alfa-epbx) as the first U.S. biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® this past May, today Pfizer announced that it has launched Retacrit® in the United States. According to reports, Pfizer began shipping Retacrit® to wholesalers on November 12, 2018, at…
Below is a summary of recent updates in biosimilar-related proceedings before the Patent Trial and Appeal Board of the United States Patent and Trademark Office. Trastuzumab: Last month, the Board issued two Final Written Decisions in IPRs of U.S. Patent No. 7,892,549, which is directed to methods for the treatment…
We have covered Pfizer’s antitrust suit against Johnson & Johnson, the manufacturer of Remicade® (infliximab). Pfizer’s suit alleges that Johnson & Johnson excluded Pfizer’s infliximab biosimilar from the market through anticompetitive bundling and rebate penalties for insurers and providers, causing inflated prices. In related litigation, retailers Walgreen and Kroger Co., direct purchasers,…
Below are some recent updates regarding U.S. regulatory submissions and a launch in connection with biosimilar products: On September 27, 2018, Samsung Bioepis announced that the U.S. FDA has accepted its aBLA for SB5, a proposed biosimilar of Humira® (adalimumab), which Bioepis submitted to the FDA in July. According to…
As we previously reported, Pfizer filed a petition for IPR of certain claims of Hoffman-La Roche’s U.S. Patent No. 8,314,225 (IPR2018-01219). According to the petition, the challenged claims “purport to claim nucleic acid sequences that encode the C-terminal part of a human immunoglobulin heavy chain and a method for improving the expression…