Sandoz, a division of the Novartis, has become the first company to develop and receive European Commission approval for its biosimilar epoetin alfa, achieving another important milestone in its efforts to bring high quality, cost-effective biological medicines to patients.
The European Commission's decision to grant this approval followed a positive opinion in June from the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP), which reviews medicines scientifically for the Commission.
More than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names to regulate the formation of red blood cells. Worldwide annual sales are estimated at more than USD 7 billion, including USD 600 million in Europe.
The European Commission has now for the second time granted to Sandoz approval for a biosimilar, which is the term for a follow-on version of a previously approved recombinant biotechnology medicine. In a precedent-setting decision in April 2006, Sandoz was the first company to obtain European approval for such a medicine, the human growth hormone Omnitrope, while US approval was granted in May 2006.
"We are pleased that the European Commission has taken the final step in approving our biosimilar epoetin alfa for marketing in Europe, and we will quickly bring this product to market for the patients and physicians who need it," said Andreas Rummelt, CEO of Sandoz. "We are committed to continue making high-quality and cost-effective biosimilars available and have several projects in our pipeline."
This approval was indicated for the use of biosimilar epoetin alfa in treating patients with renal anaemia as well as those receiving chemotherapy.
Sandoz has been on the forefront of efforts to support the creation of regulatory review procedures to enable the approval of biosimilar medicines. Rigorous scientific criteria should be consistently applied to the approval process for these types of medicines. However, unnecessary or unethical duplication of animal studies and human trials should be avoided, as is the case with other types of subsequent versions of medicinal products.
As more biopharmaceuticals lose patent protection in the coming years, these products are expected to play a key role in the growth strategy of Sandoz.
Biopharmaceuticals are medicinal products manufactured by biotechnology methods. They are complex protein molecules with a high molecular weight derived from living organisms that have been genetically modified to produce the desired protein. Using advanced product development, applying the "quality by design" approach, analytical methodologies and manufacturing processes, companies like Sandoz can manufacture high quality medicines and bring them to market with savings for patients and payors.
Sandoz, a division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, cost-efficient products that are no longer protected by patents. Sandoz has a portfolio of more than 840 compounds in over 5 000 forms worldwide.