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What are Biosimilars?

What are Biosimilars?

A biosimilar is a medicine with an active pharmaceutical ingredient produced using biotechnology and which is developed in comparison to an original product already on the market. The biosimilar is so similar to the original product that it has proven therapeutic equivalence and is comparable in terms of safety and quality. A biosimilar is thereby an equivalent successor product of an off-patent biopharmaceutical product.

There is a particular challenge to biopharmaceuticals: As opposed to chemically produced drugs, they are produced using a biotechnical process within living cell cultures. Due to this complex production technique, the sophisticated physical-chemical analysis and the comprehensive clinical studies required for successful approvals, medicines produced using biotechnology count among the most expensive medicines on the market today. They are used in many areas, such as for the treatment of cancer, diabetes, rheumatoid arthritis and the treatment of dialysis patients.

Are biosimilars cheaper than original products?

When the original biopharmaceutical producer's patent expires, the medicine can also be produced and sold by other suppliers. This leads to more competition and decreased costs.

The price difference between a biosimilar and the original product is, however, smaller than that between a generic and an original drug. This is because biosimilars are produced using a highly complex biotechnological process and the manufacturers must make heavy investments in clinical studies, challenging production processes and the approval of European approval authorities.

Biosimilars, nevertheless, represent a clear price advantage as compared to the original products. According to current statistics, savings range from approx. 20 to 25% (source: Pro Generika e.V.), which represents a significant relief for health care systems.

Are biosimilars equivalent to original products?

Biosimilars are tested by the European Medicines Agency (EMA) for quality, effectiveness and safety before they can be marketed in Germany and other European countries. Once a medicine is approved, the European Commission then confirms that the biosimilar is equivalent to the original product in terms of effectiveness, quality and safety. After approval, biosimilars are subject to the same strict requirements and ongoing monitoring of authorities as the products of the original producer.

What biosimilar products does STADA have?

STADA already has long-standing experience in this relatively young area of medicine. STADA introduced a biosimilar for the therapeutic areas of nephrology and oncology as early as 2008. In August 2014, another biosimilar was introduced for the indication of chemotherapy-induced neutropenia.

Furthermore, there has been a cooperation with Gedeon Richter since 2011 which includes, among other things, a biosimilar for the area of oncology used for non-Hodgkin lymphoma, for example, or for the treatment of autoimmune diseases such as rheumatoid arthritis. Pending successful development, this product is expected to launch in the year 2018.

Moreover, we expanded our biosimilar portfolio in 2014 by in-licensing a biosimilar for the indication of osteoporosis. From today's perspective, we expect to launch this product in 2019 pending successful development and the expiration of patent protection. We are also continuously reviewing options for in-licensing biosimilars in various indication areas with the goal of remaining capable of expanding our biosimilar portfolio in future.

Furthermore, in 2015, a license and sales agreement with Gedeon Richter regarding a biosimilar for the treatment of neutropenia, which is to be launched to the market in 2017 upon patent expiry, was signed. This illness is a common side effect of cytotoxic chemotherapies and results from a low amount of certain white blood cells.

Find out more about biosimilars and the effects on the health care system in a video by the German Pro Generika association (video in German only):

Why do biosimilars relieve the German healthcare system?

Scientific studies show that many affected people in Germany have limited access to biopharmaceuticals compared to other European countries. This is because the new treatment options that were created with the highly effective biopharmaceuticals in the area of serious and life-threatening diseases are very expensive and are therefore often prescribed with reluctance. Due to their cost advantage, modern biosimilars offer the opportunity to fill this gap in the supply of pharmaceutical products. In view of this, biosimilars relieve the German healthcare system and thus support the medicine supply in Germany. For that reason, biosimilars will play an increasingly important role for the medicine supply in the years to come.

STADA, too, is active in the biosimilars area and, as a founding member, supports the “Arbeitsgemeinschaft Pro Biosimilars” (Pro Biosimilars Association) – an association representing the German biosimilars companies established under the umbrella of Pro Generika e.V. Since May 2015, the association has been committed to helping patients gain access to modern therapies involving biopharmaceuticals and to making treatments that meet the medicinal needs more affordable on a long-term basis.

For further information on the Association Pro Biosimilars, go to: www.probiosimilars.de (German only)


On the occasion of World Rheumatism Day 2015, Association Pro Biosimilars published a film about rheumatism which explains the opportunities biosimilars offer for our healthcare system. (Video in German only)

 


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