On September 2, 2021, the parties in the Amgen v. Hospira (D. Del., No. 18-1064) Neupogen®/filgrastim litigation submitted a stipulation and proposed order to dismiss all claims and counterclaims in the litigation, with prejudice. The Court (Judge Connolly) has not yet entered the order of dismissal on the docket. The…
Last week, Pfizer announced that it will acquire Trillium Therapeutics, a clinical stage immune-oncology company based in Cambridge, Massachusetts. Under the agreement, Pfizer reported that it “will acquire all outstanding shares of Trillium not already owned by Pfizer for an implied equity value of $2.26 billion, or $18.50 per share,…
On July 29, 2021, the American Academy of Ophthalmology (AAO) released a statement urging the Centers for Medicare & Medicaid Services (CMS) to prohibit Insurance companies from requiring ophthalmologists to use new biosimilar drugs as alternatives to Avastin for treatment in eye diseases. The statement alleges that certain large healthcare…
On July 20, 2021, after nearly four years of litigation, Johnson & Johnson (J&J) and Pfizer have agreed to dismiss all claims asserted in the antitrust suit brought by Pfizer in the Eastern District of Pennsylvania regarding Remicade (infliximab). Remicade is an immunosuppressant that is used to treat Crohn’s disease,…
On June 16, 2021, the District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim). In the Order, the Court construed the term “between about 0.1 M…
At the end of last month, Judge Connolly denied defendants Hospira and Pfizer’s motion to dismiss following a telephone conference with the parties. We previously reported back in February 2020 that Amgen sued Pfizer and its affiliate Hospira for patent infringement of U.S. Patent No. 8,273,707 (“’707 patent”) based on…
In honor of Women’s History Month, Big Molecule Watch continues to highlight the work of women who have contributed to the advancement of biologics and biosimilars. One such individual is Emer Cooke, who is the first woman to occupy the role of Executive Director of EMA and to lead that…
Below are some highlights from fourth quarter and full year 2020 earnings reports recently released by biologics and biosimilars companies: At the end of last month, Johnson & Johnson reported fourth quarter sales of $22.5 billion reflecting growth of 8.3% and full year sales of $82.6 billion reflecting growth of…
At its January meeting last week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval for two biosimilar bevacizumab medicines, Alymsys and Oyavas. Mabxience Research SL’s Alymsys and STADA Arzneimittel AG’s Oyavas both received positive opinions for the treatment of carcinoma of the colon or rectum, breast cancer, non-small…
We have previously reported that Mylan and Upjohn, Pfizer’s off-patent branded and generic business, are combining to form a new company. We also reported that although the planned integration has been delayed because of the COVID-19 pandemic, the transaction is expected to close in the second half of 2020. Last…