Below are highlights of recent developments in biosimilar clinical trials. On December 9, Celltrion presented the results from a phase 3 clinical trial that demonstrated similar safety and efficacy of its TRUXIMA biosimilar to the reference product RITUXAN (rituximab) in patients with advanced follicular lymphoma (AFL). On December 10, Samsung…
Today, the World Health Organization (“WHO”) prequalified Samsung Bioepis’s breast cancer biosimilar trastuzumab – WHO’s first biosimilar prequalification. Prequalification is “a service provided by WHO to assess the quality, safety and efficacy of those products that address global public health priorities.” The WHO noted that the global average price of…
This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against Hospira, a subsidiary of Pfizer, regarding a biosimilar of Amgen’s EPOGEN (epoetin alfa). On…
On December 10, 2019, the House Democrats and Trump administration reached an agreement on the United States-Mexico-Canada Agreement (USMCA), which would replace the North American Free Trade Agreement (NAFTA) of 1994. According to CNBC, the final version does not include a 10-year data exclusivity period for biologic drugs that was part…
As previously reported, earlier this year Fresenius filed a petition for inter partes review of claims 9-10, 13-21 and 23-30 of Amgen’s pegfilgrastim patent – U.S. Patent No. 9,643,997 (“997 patent”). The challenged claims of the ’997 patent relate to methods for purifying proteins of interest expressed in a non-native…
As we previously reported, earlier this year Coherus filed a complaint against Amgen in the District of Delaware alleging infringement of patents claiming “stable aqueous pharmaceutical compositions” comprising adalimumab and other components. Coherus alleged that “Amgen is actively offering for sale and selling Amgevita™ [Amgen’s tradename for its adalimumab biosimilar…
Today, the FDA approved Amgen’s AVSOLA (infliximab-axxq), a biosimilar to Janssen’s REMICADE. AVSOLA has the same approved indications label as its reference product. AVSOLA is the third biosimilar to REMICADE to receive FDA approval, after INFLECTRA and RENFLEXIS, and the 26th FDA-approved biosimilar overall.
This week, several companies reported updates in their clinical development of biosimilars or follow-on biologics. On December 3, Outlook Therapeutics (formerly known as Oncobiologics) announced the FDA agreed with three of Outlook’s proposed Special Protocol Assessments (“SPAs”) relating to ONS-5010, an investigational ophthalmic formulation of bevacizumab which is currently in…
Yesterday, Mylan N.V. and Biocon Ltd. announced the U.S. launch of OGIVRI (trastuzumab-dkst), a biosimilar to HERCEPTIN (trastuzumab). According to the press release, “OGIVRI™ is approved for all indications of HERCEPTIN® including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma),” and is available in both…
Beginning on March 23, 2020, the FDA will begin to accept aBLAs for biosimilar insulin products referencing previously approved insulin products. Prior to this date, insulin products have been approved pursuant to New Drug Applications and, thus, insulin generics were not eligible for approval as aBLAs. The transition period for…