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Genentech and Amgen file stipulations in the US District Court of Delaware dismissing their BPCIA litigation relating to trastuzumab and bevacizumab biosimilars. This comes after the Court of Appeals refused to block Amgen’s Mvasi® from entering US markets on July 06....

Outlook Therapeutics announces it has completed patient enrolment for its NORSE 2 clinical trials of Lytenava® (proposed bevacizumab biosimilar).

Significant biosimilar activities this week include
28 Jun 20 | US Genentech filed a complaint against Samsung Bioepis in the District Court of Delaware under the BPCIA, alleging infringement of 14 patents related to SB8 (Samsung’s proposed bevacizumab biosimila...

In its 2019-2020 Annual Report, Biocon announced it plans to list Biocon Biologics on Indian markets within the next two to three years, depending on market conditions.

US Senators John Cornyn (R-TX) and Michael Bennet (D-CO) introduced the Increasing Access to Biosimilars Act, aimed at reducing the cost of prescription drugs for seniors. The proposed measures include promoting competition, increasing access to biosimilars, and encouraging...

The National Comprehensive Cancer Network (NCCN) announced it will collaborate with Pfizer Global Medical Grants to offer grants in support of the adoption of biosimilars in oncology. The NCCN has asked applicants to submit Letters of Intent which describe ‘concepts t...

Sandoz responds to the US Court of Appeals judgment which upheld a ruling from the New Jersey District Court which declared the Amgen patents relating to (etanercept) valid. Sandoz stated that it will continue its efforts to make Erelzi® available in the US, and is evaluati...

The US District Court of Delaware refuses to combine Amgen’s two actions against Pfizer and Hospira relating to filgrastim. The original action was filed in July 2018, and the more recent action was filed in April 2020. In the oral order, (available courtesy of Goodwi...