Last Friday, Japanese company Mochida Pharmaceutical with Korean company LG Chem announced that it has received sales approval from the Japanese Ministry of Health, Labour and Welfare on its etanercept biosimilar (marketed by Amgen as ENBREL®) for the treatment of rheumatoid arthritis and juvenile idiopathic arthritis. LG Chem has a…
As we previously reported, on October 6, 2017, Amgen and Genentech filed separate lawsuits regarding Amgen’s bevacizumab biosimilar (MVASI®), with Amgen filing for declaratory judgment in C.D. Cal. of non-infringement, invalidity, and unenforceability of 27 patents, and Genentech filing a complaint for infringement of 24 patents in Delaware and a…
A research letter published by the British Journal of Dermatology from investigators in Samsung Bioepis’s biosimilar etanercept (SB4) clinical trials reports that, in addition to therapeutic equivalence between SB4 and reference etanercept (Enbrel), SB4 has been found to be less immunogenic than reference etanercept. The letter notes that injection site…
Sandoz, a division of Novartis, announced on Tuesday that the FDA has accepted for review its BLA under the 351(k) pathway for a biosimilar candidate to AbbVie’s Humira (adalimumab). According to the press release, adalimumab “is indicated for the treatment of a number of inflammatory diseases including rheumatoid arthritis, plaque psoriasis,…
As we previously reported, Genentech has filed two pending cases (Case Nos. 1:17-cv-01407 and 1:17-cv-01471) in the District of Delaware related to Amgen’s proposed Mvasi (bevacizumab-awwb), a biosimilar of Genentech’s Avastin. On December 6, 2017, Genentech filed a sealed amended and supplemental complaint in Case No. 1:17-cv-01407, and on December 13, Genentech filed a redacted version. Last month Amgen…
On January 11, FDA announced the release of its 2018 Strategic Policy Roadmap, which provides an overview of several policy areas that FDA intends to focus on in 2018. FDA noted that, among these policy areas, it planned to “leverage innovation and competition to improve health care, broaden access, and…
In its 2018-2022 National Health Strategy, France aims for 80% biosimilar penetration by 2022, an increase from last year’s 70% target. France’s support for biosimilars is not new. Its 2014 budget pushed for pharmacy-level substitutions, and in 2017 the substitution policy was revamped and a biosimilar registry was created. Although…
On January 8, 2018, the Federal Circuit issued its en banc decision in Wi-Fi One, LLC v. Broadcom Corp., No. 2015-1944. The Federal Circuit originally held that due to binding precedent, a time-bar determination under 35 U.S.C. § 315(b) is final and nonappealable under 35 U.S.C. § 314(d). As we reported here,…
Below is a roundup of several recently published comparative studies between biosimilars and reference biologics. In a study presented at the American Society of Hematology’s 59th Annual meeting, the authors concluded that there were no clinically meaningful differences in the safety profile of Cinfa Biotech’s B12019 biosimilar to Neulasta® (pegfilgrastim) compared with…
Last week, Oregon passed a law that allows pharmacists to automatically substitute a biosimilar with a prescribed biological product. According to their new legislation, before a biosimilar can be automatically substituted, it must be approved by the FDA to be “interchangeable,” and the prescriber must not have forbidden the substitution. Oregon…