European Commission Approval for biosimilar epoetin alfa

Sandoz 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 anemia 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.

About Sandoz
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. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments and hormone therapies. Sandoz develops, produces and markets these drugs along with pharmaceutical and biotechnological active substances and Anti-Infectives. In addition to the strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany) and EonLabs (U.S.) and sells its products in more than 110 countries. In 2006, Sandoz employed around 20,000 people worldwide and posted sales of USD 6 billion.
www.sandoz.com

Most Popular Now

Time-restricted eating reshapes gene expression th…

Numerous studies have shown health benefits of time-restricted eating including increase in life span in laboratory studies, making practices like intermittent fasting a ...

Incurable liver disease may prove curable

Research led by Associate Professor Duc Dong, Ph.D., has shown for the first time that the effects of Alagille syndrome, an incurable genetic disorder that affects the li...

Scientists develop a cancer vaccine to simultaneou…

Scientists are harnessing a new way to turn cancer cells into potent, anti-cancer agents. In the latest work from the lab of Khalid Shah, MS, PhD, at Brigham and Women’s ...

AstraZeneca to acquire CinCor Pharma to strengthen…

AstraZeneca has entered into a definitive agreement to acquire CinCor Pharma, Inc. (CinCor), a US-based clinical-stage biopharmaceutical company, focused on developing no...

NextPoint Therapeutics announces $80 million Serie…

NextPoint Therapeutics, a biotechnology company developing a new world of precision immuno-oncology, announced today that it raised $80 million in Series B financing co-l...

COVID-19 vaccines, prior infection reduce transmis…

Vaccination and boosting, especially when recent, helped to limit the spread of COVID-19 in California prisons during the first Omicron wave, according to an analysis by ...

Bayer to accelerate drug discovery with Google Clo…

Bayer AG and Google Cloud announced a collaboration to drive early drug discovery that will apply Google Cloud's Tensor Processing Units (TPUs), which are custom-develope...

Study identifies potential new approach for treati…

Targeting iron metabolism in immune system cells may offer a new approach for treating systemic lupus erythematosus (SLE) - the most common form of the chronic autoimmune...

Nanotechnology may improve gene therapy for blindn…

Using nanotechnology that enabled mRNA-based COVID-19 vaccines, a new approach to gene therapy may improve how physicians treat inherited forms of blindness. A collabo...

Acquisition of Neogene Therapeutics completed

AstraZeneca has completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and ...

Modified CRISPR-based enzymes improve the prospect…

Many genetic diseases are caused by diverse mutations spread across an entire gene, and designing genome editing approaches for each patient’s mutation would be impractic...

Pfizer expands 'An Accord for a Healthier World' p…

Pfizer Inc. (NYSE: PFE) announced that it has significantly expanded its commitment to An Accord for a Healthier World to offer the full portfolio of medicines and vaccin...