Stada Launches Bevacizumab Biosimilar

Stada Arzneimittel has received European Commission approval for the bevacizumab biosimilar Oyavas and has immediately launched the product in Germany and the Netherlands.

“Launches in other European countries will follow soon, depending in part on national pricing and reimbursement clearance,” the company said in a statement.

The launch is in partnership with mAbxience, which is an established biosimilar supplier in Latin America.

Stada, based in Bad Vilbel, Germany, said data submitted for the European marketing authorization demonstrated that the biosimilar is equivalent to the reference product (Avastin) in terms of quality, safety, and efficacy for the treatment of colon, rectal, breast, and non–small cell lung cancers, in addition to epithelial ovarian, fallopian tube, cervical, and primary peritoneal cancers.

“Through partnerships, STADA has built a comprehensive biosimilars portfolio and pipeline, not only in oncology, but also in therapeutic areas such as autoimmune disorders, osteoporosis, and ophthalmology, as the group continues to strengthen its presence in the specialty pharma sector, said Stada CEO Peter Goldschmidt.

Also of Note

mAbxience recently announced plans to strengthen its biosimilar production capacity in Leon, Spain.