The Top 5 Biosimilars Articles for the Week of December 10

The Center for Biosimilars® recaps the top news for the week of December 10, 2018.


Hi, I’m Samantha DiGrande for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilars articles for the week of December 10.

Number 5: Novartis recently announced that ligelizumab is moving on to phase 3 trials after demonstrating a clear dose-response relationship and improvements over another one of its older products, omalizumab.

Number 4: Since biosimilar filgrastim became available, patient access to the treatment has improved in many regulatory markets, but concerns still remain about whether the United States is keeping place with the rest of the world in biosimilar uptake.

Number 3: Amgen and Entera Bio have announced that they have entered into a research collaboration and license agreement to develop orally administered formulations of biologic drugs.

Number 2: This week, the FDA took significant steps toward a long-awaited transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars.

Number 1: Genentech and Pfizer have filed a collective stipulation and proposed order of dismissal of a patent infringement lawsuit over Genentech’s reference trastuzumab product, Herceptin.

Finally, last week, our e-newsletter asked if you think there will be more developers sponsoring biosimilars of drugs that treat rare diseases.

To view results of the poll, visit us on LinkedIn.

To read all of these articles and more, visit