Seeking to develop a biosimilar portfolio, Stada Arzneimittel has launched Oyavas in Germany and the Netherlands.
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.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.
BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?
November 4th 2024The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.