cGMP Approval from U.S. FDA Still Awaited
Binex has recently passed the Good Manufacturing Practices (GMP) inspection conducted by the European Medicines Agency (EMA). This milestone marks a significant achievement for the company, which has undergone stringent and rigorous inspections from both the EMA and the U.S. Food and Drug Administration (FDA) this year to supply global commercial pharmaceutical products for biosimilar products developed by global biosimilar companies.
The successful completion of the EMA inspection demonstrates Binex's GMP facilities and quality management capabilities, which meet the high standards required by global regulatory agencies. "We have passed the Good Manufacturing Practices (GMP) inspection conducted by the European Medicines Agency (EMA)," the company announced on Nov. 11. "With the successful completion of this inspection, we have once again demonstrated that we possess GMP facilities and quality management capabilities that meet the standards required by global regulatory agencies."
Binex obtained GMP approval from the EMA first, ahead of the U.S. FDA's cGMP approval, which the company is still awaiting. This approval is crucial for Binex as it aims to supply global commercial pharmaceutical products for biosimilar products. Biosimilars are biologic medical products that are almost identical copies of an original product manufactured by a different company. They offer more affordable treatment options for patients and are officially approved versions of original "innovator" products that can be manufactured once the original product's patent expires.
With the successful EMA inspection, Binex plans to continuously produce and supply commercial biosimilar products to Europe, the largest market for biosimilars. Europe has a supportive regulatory environment and a high demand for cost-effective biologic treatments, making it a robust market for biosimilars. The EMA has been proactive in creating a framework for the approval of biosimilars, which has contributed to the growth of this market in the region.