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,…
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…
It has been reported that manufacturer AbbVie will increase the price of Humira® (adalimumab) by 9.7% in 2018. According to Wells Fargo analyst David Maris, this price increase could add an additional $1.2 billion to the U.S. healthcare system’s drug costs. Humira® currently generates over $10 billion in revenue in…
Hetero announced this week the launch in India of its adalimumab biosimilar, marketed under the brand name Mabura. Mabura is a biosimilar of AbbVie’s Humira and is indicated for the treatment of rheumatoid arthritis and other auto-immune disorders. According to the company, Mabura is Hetero’s fourth biosimilar product. Glenmark also announced this…
As we reported previously, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product and remanding the appeal to the district court for a new trial on the defendants’ written description and enablement defenses. Amgen…