- STADA introduces bevacizumab biosimilar in Germany and the Netherlands upon regulatory approval, with several more countries to follow soon
- Bevacizumab joins not only STADA’s existing oncology biosimilars, epoetin zeta and pegfilgrastim, but also rounds out a comprehensive offering for oncologists and their patients such as a convenient ready-to-use formulation of bortezomib
- STADA CEO Peter Goldschmidt: “Introducing bevacizumab is testament to STADA’s strategy of being a go-to-partner for enabling patient access to biosimilars in Europe.”
STADA has broadened its specialty oncology portfolio by introducing biosimilar bevacizumab upon receiving a pan-European marketing authorisation. The cancer treatment is now available to oncologists and their patients in Germany and the Netherlands, while launches in other European countries will follow soon, depending in part on national pricing and reimbursement clearance.
The launches in Germany and the Netherlands come immediately after receipt of a centralized marketing authorisation from the European Commission. STADA has brought the monoclonal antibody to market through a partnership with Spanish developer and manufacturer mAbxience, which has extensive experience supplying bevacizumab in markets such as Latin America since 2016. Under the terms of an agreement with mAbxience, STADA holds the marketing authorisation and sales and marketing rights in around 40 European countries, including all 27 European Union member states.
“Introducing the new biosimilar is testament to STADA’s strategy of being a go-to-partner for enabling patient access to biosimilars in Europe,” commented STADA CEO Peter Goldschmidt. “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.”
STADA has been engaged in bringing biosimilars to patients and healthcare professionals since founding the Bioceuticals Arzneimittel AG in 2000. Thereby, STADA contributes to the cost effectiveness of healthcare systems. The company has 13 years of market experience with its epoetin zeta treatment that has become one of STADA’s best-selling products since its launch in 2008. In the oncology sector, STADA also offers pegfilgrastim for stimulating the production of white blood cells, while STADA’s marketed biosimilars portfolio includes teriparatide.
Through several partnership strategy and co-development alliances, STADA’s biosimilars pipeline encompasses several product candidates aimed at treating cancer. Other pipeline molecules are intended for autoimmune and inflammatory conditions as well as for ophthalmology uses.
In January 2021, the European Medicines Agency (EMA) had recommended via a ‘positive opinion’ granting approval to the new bevacizumab for infusion. The CHMP determined that data show the biosimilar is highly similar and has comparable quality, safety and efficacy to the reference product for treating carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.