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…
We have been covering Pfizer’s antitrust suit against Johnson & Johnson (J&J), the manufacturer of Remicade® (infliximab). As we previously reported, Pfizer filed an antitrust lawsuit in September 2017 against J&J in the U.S. District Court for the Eastern District of Pennsylvania alleging that J&J has engaged in an anticompetitive scheme…
As we previously reported, on February 11, 2020, Amgen sued Pfizer and its affiliate Hospira, alleging that their proposed biosimilar of Amgen’s NEULASTA (pegfilgrastim) would infringe U.S. Patent No. 8,273,707 (“the ’707 patent”). The ’707 patent is directed at methods of protein purification. Last week, Pfizer filed a motion to…
On February 11, 2020, Amgen sued Pfizer and its affiliate Hospira for patent infringement based on their proposed biosimilar of NEULASTA (pegfilgrastim). Pegfilgrastim is indicated for decreasing the incidence of infection in patients receiving myelosuppressive chemotherapy. In the complaint, Amgen alleges that Hospira’s aBLA infringes U.S. Patent No. 8,273,707 (“the…
Today, Pfizer announced that it has launched or is launching the following three biosimilars in the United States at the following prices: ZIRABEV (bevacizumab-bvzr), which was introduced to the U.S. market on December 31, 2019, at a Wholesale Acquisition Cost (WAC) of $61.34 per 10 mg, which represents a 23%…
Earlier this week, during its 3Q 2019 earnings call, Pfizer announced the U.S. launch dates for three of its biosimilar products: ZIRABEV (bevacizumab-bvzr), a biosimilar of Genentech’s AVASTIN, which received approval in June, will launch December 31, 2019. We previously posted that on September 20, 2019, Genentech and Pfizer settled…