The Top 5 Biosimilar Articles for the Week of August 30

Hi, I’m Skylar Jeremias 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 biosimilar articles for the week of August 30, 2021.

Number 5: Cipla, a medicines developer and retailer, and Kemwell Biopharma, a contract manufacturer, intend to produce biosimilars for lung disorders.

Number 4: Bio-Thera Solutions has partnered with Hikma Pharmaceuticals for the commercialization of a proposed ustekinumab biosimilar (BAT2206) for the treatment of chronic inflammation.

Number 3: The European Union has approved its first ranibizumab biosimilar (Byooviz, SB11), a Samsung Bioepis product that references Lucentis.

Number 2: The International Psoriasis Council (IPC) reaches consensus on switching, patient agreement, and biosimilar safety and efficacy qualification. The IPC guidance is conservative when it comes to substitution of these products.

Number 1: Clinical efficacy studies are not always required for biosimilars, and it's possible to resist if the FDA does ask for them. Sarfaraz K. Niazi, PhD, suggests a game plan.

To read all of these articles and more, visit centerforbiosimilars.com.