The Biosimilars Group Office

The Biosimilars Group, an alliance of 5 companies experienced in biosimilars development, starts operations today

Mannhein, Germany: September 22, 2014 – Five pharmaceutical service providers (Assign International GmbH, Aurigon GmbH, Celonic AG, Protagen Protein Services GmbH and PharmaLex GmbH) have formed The Biosimilars Group in July 2014. This new company has started operations today and offers a complete service portfolio for the biosimilars industry, including analytics driven biosimilars development, process development and manufacturing, non-clinical and clinical testing, as well as regulatory and pharmacovigilance support. Companies engaged in the development of biosimilars may choose some or all services of The Biosimilars Group depending on their unique needs.

Many blockbuster biologics are facing patent expiries in the next few years. At the same time the regulatory requirements for development of biosimilars have become clearer; for example the FDA has issued an increasing number of guidance documents on biosimilars development. And in addition, the high cost pressure on the health care systems worldwide creates market opportunities for new biosimilars, which are less costly than the originator biotech products. Given these developments, more and more companies are entering the biosimilars’ field. For these companies it is essential to coordinate complex activities in drug development in a very short time frame and cooperate with experienced partners. Increased efficiency will lead to substantial savings in development time and budget.

“The Biosimilars Group is an ideal partner for companies developing biosimilars, as we can navigate our clients through all challenges in biosimilars drug development, while offering a one-stop global solution,” says Tilo Netzer, PhD, responsible for Regulatory Affairs and Pharmacovigilance at The Biosimilars Group. Martin Blüggel, responsible for analytics driven biosimilars development, adds: “At the same time, we provide maximum flexibility to our customers which cannot be achieved by one Contract Research Organization engaged in this field”.

The members of The Biosimilars Group are all renowned service providers with a proven track record in biosimilars development. They have successfully completed over 80 projects across all functions in the past 5 years and have more than 10 years of experience in biosimilars development. Overall, there are more than 500 highly qualified professionals now employed in the group. The partner companies operate in more than 15 sites on three continents.

The Biosimilars Group will be available for partnering discussions at the BIO-Europe Conference in Frankfurt/Main, Germany, on November 3-5, 2014.

Media Contact: TBD, +49 (0) 621 76449064,