Markets & Regulations

European group criticizes proposed WHO, FDA biosimilar naming schemes

European group criticizes proposed WHO, FDA biosimilar naming schemes

By Zachary Brennan

The EBG (European Biosimilars Group), a part of the EGA (European Generic Medicines Association), says that more complex systems for naming biosimilars increases the likelihood that physicians and pharmacists will leave something out and disrupt the tracking...

US CMS releases new info around biosimilar pricing, uptake

US CMS releases new info around biosimilar pricing, uptake

By Zachary Brennan

With the release of four different documents around the pricing and use of biosimilars this week, the US CMS (Centers for Medicare and Medicaid Services) is making clear it will fully encourage states to call on prescribers to use cost-effective biosimilars...

Photo from Schoolhouse Rock

California, Illinois propose biosimilar substitution bills

By Zachary Brennan

More than a year since California saw its previous biosimilar substitution bill vetoed by its governor and more than two years since Illinois tried its hand, both are again looking to become the ninth and tenth states to see new substitution laws.

Japanese companies acquire CMO KBI Biopharma

Japanese companies acquire CMO KBI Biopharma

By Zachary Brennan

Tokyo-based CMIC Holdings Co., Innovation Network Corporation of Japan (INCJ), and JSR have agreed to acquire KBI Biopharma, a contract development and manufacturing organization with facilities in Durham and Research Triangle Park, North Carolina and...

Hospira launch biosimilar mAb in the EU

Hospira launches first mAb biosimilar in major EU markets

By Zachary Brennan

Hospira, recently acquired by Pfizer, announced Monday the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets, following the patent expiry of J&J’s Remicade. 

Sanofi headquarters

Sanofi to hike biologics CapEx in 2015

By Gareth Macdonald

Sanofi will invest in biologics and vaccine manufacturing capacity in 2015 to sustain product launches and ease constraints that impacted its Sanofi Pasteur division in the past few years.