Pearce IP BioBlast: w/e 03 July 2020
Significant biosimilar activities this week include:
June 28 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 biosimilar), and violation of the "patent dance" provisions.
June 28 EU: Celltrion announced EU's CHMP recommended expanding the marketing authorisation for its subcut Remsima® (biosimilar infliximab) to include the following additional indications: IBD, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis. This extends the indications beyond RA which was approved in November 2019.
June 28 US: Outlook India reported Dr Reddy's is expecting to launch 25 products in the US market in the current financial year and that Dr Reddy's Ph III trials of a proposed rituximab biosimilar are progressing as planned.
June 29 US: in a letter to the Editor published by the Washington Post, Keith Webber (former acting director of the FDA's Office of Biotechnology Products and Office of Generic Drugs) highlighted the potential consequences of the legal brief filed in the US Supreme Court by the Trump administration. The Trump brief, filed on June 25, argues that the Affordable Care Act should be overturned as unconstitutional. Webber underscores that if Obamacare is overturned, the BPCIA would also be eliminated, removing the FDA's ability to approve biosimilars and potentially effecting biosimilars previously approved.
June 29 JP: Fujifilm Kyowa Kirin Biologics announced manufacturing and marketing approval in Japan for FKB237 (adalimumab biosimilar). This product was developed in partnership with Mylan and has been marketed as Hulio® in 20 countries across Europe.
June 29 EU: Adalvo announced EU's CHMP has adopted a positive opinion for Livogiva® (biosimilar teriparatide injection) for use in postmenopausal women with osteoporosis who are at high risk of having bone fractures.
June 29 US: Merck announced FDA has approved Keytruda® (pembrolizumab) for first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
June 30 CN: BeiGene announced its has begun commercialising Xgeva® (denosumab) in China. Xgeva® was developed by Amgen, and is the first of the products to be commercialised by BeiGene under a January 2020 agreement.
June 30 Global: Samsung Bioepis announced it has commenced Ph III trials of SB15, proposed aflibercept biosimilar.
June 30 AU: Amgen received Australian approval for Mvasi® (biosimilar bevacizumab) for all indications as Avastin®.
June 30 US: the US District Court of Delaware refused 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 Goodwin), the Court ruled that as Amgen would not agree to use the same experts for both cases, they should bear the consequences of litigating an action nearly two years after the original action. The Court also indicated that it would entertain Pfizer/Hospira's proposed motion to stay the second action.
July 01 US: Sandoz responded 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 evaluating its options, including a possible appeal to the US Supreme Court.
July 01 US: 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 that develop and validate enduring approaches to improve the safe, effective and efficient adoption of biosimilars in oncology'.
July 01 US: 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 physicians to prescribe biosimilars.