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…
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…
We previously posted that in August 2017, Samsung Bioepis’ adalimumab biosimilar, SB5 (also known as Imraldi®), was granted marketing authorization by the European Commission. In September, it also won approval from the South Korean Ministry of Food and Drug Safety. SB5 is a biosimilar for Humira®, which is approved for…
Last week FDA issued new guidance for industry and FDA review staff, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance is intended to “describe best practices and procedures for timely, transparent, and effective communications between [IND] sponsors and FDA at critical junctures in…
Yesterday, Momenta Pharmaceuticals and Mylan announced a development strategy for M710, a proposed biosimilar of Regeneron’s Eylea® (aflibercept), including their plan to initiate a pivotal clinical trial in the first half of this year. According to the joint press release, the trial will be a randomized, double-blind, active-control, multi-center study in…
As we frequently report here on the blog, there has been increasing activity in BPCIA litigation concerning a variety of proposed and marketed biosimilar products. The coming year is likely to bring even more activity, with three cases scheduled for trial, several others in discovery or appeal, and new complaints likely. …
Goodwin and the Big Molecule Watch team are looking forward to participating in the 36th Annual J.P. Morgan Healthcare Conference, bringing together industry leaders from across the country. If you are planning to attend the conference in San Francisco, we hope you will join the team next Wednesday, January 10,…