Today, the FDA approved Samsung Bioepis’s Ontruzant (trastuzumab-dttb), a biosimilar to Genentech’s Herceptin (trastuzumab), for the treatment of patients with HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Samsung Bioepis’s product is the subject of ongoing BPCIA litigation, pending before the District of Delaware. This is the third biosimilar…
During the first weeks of 2019 a number of biosimilar developers announced updates regarding their plans for the future. Bio-Thera Solutions Partners with Cipla for Bevacizumab Biosimilar Candidate On January 14, 2019, Bio-Thera Solutions Ltd announced that it has entered into a licensing agreement with Cipla Limited for BAT-1706, its…
As the government shutdown continues, administrative agencies have been updating the public on their operating status. The FDA has released a statement on its website explaining that its operations will “continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human…
In a tweet today, FDA Commissioner Scott Gottlieb stated: “FDA continues to be concerned about branded companies creating confusion about the safety and effectiveness of biosimilars and we’ll take action if we determine a company is deliberately misleading the public about the safety of these important products.” The communication comes in response…
Goodwin and the Big Molecule Watch team are looking forward to participating in the 37th Annual JP Morgan Healthcare Conference, bringing together industry leaders from across the country. If you are at the conference in San Francisco, we hope you will join the team today, January 9, 2019 for our…
Coherus Biosciences announced today that it has entered into a $75 million senior secured credit facility agreement with Healthcare Royalty Partners. According to the press release, the funds will be used to “accelerate and enhance the manufacture and sale of UDENYCA (pegfilgrastim-cbqv).” The press release also confirms that UDENYCA launched…
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…
Yesterday, Kashiv Pharma, LLC announced its acquisition of the assets of Adello Biologics, LLC, a biotechnology company developing biosimilars. Kashiv will now be known as Kashiv BioSciences, LLC with its headquarters in Bridgewater, New Jersey. It also has research and development and manufacturing facilities in Bridgewater, New Jersey, Piscataway, New…
Here are our picks of some legal developments to keep an eye out for in the new year: Etanercept biosimilar trial decision – This past September, in the Immunex v. Sandoz BPCIA patent litigation concerning Sandoz’s Erelzi™ (etanercept-szzs), an FDA-approved but yet-unmarketed biosimilar of Enbrel®, the New Jersey district court…
Here are our picks for the most significant U.S. regulatory developments related to biosimilars in 2018: 1. FDA Releases Biosimilars Action Plan In July, FDA released the Biosimilar Action Plan (BAP), which outlines the Administration’s proposed next steps to help reduce the costs of healthcare by expediting the development of…