Germany Becomes Biosimilar HotSpot

Germany Becomes Biosimilar HotSpot

Germany is the leading market and also the highest-growth market for biosimilars.  These close copies of biodrugs work in this market for many reasons but mostly because pricing pressures are the greatest. Kalorama Information estimates that the nation represents 1/5th of the biosimilars market in the world, according to our latest report, Kalorama's Biosimilars: Global Market, Trends and Competitor Analysis.

Germany's Federal Healthcare Committee, which determines which products are reimbursed, has given biosimilars the stamp of approval and has endorsed them fully. This has had a huge influence on local prescribing and dispensing decisions. Also, the 250 individual health insurance funds (Krankenkassen) have endorsed biosimilars, realizing the savings from biosimilar dispensing. Binocrit, which was launched in Germany in 2007 is gaining market share for Sandoz. In Germany, biosimilars are generally accepted as people know they are safe and as effective as the innovator drugs and they are substitutable. Germany holds approximately 34% of the total European biosimilars market. This has created a very favorable market for biosimilars in Germany.

As a course of history, the EU is the first in the world to have defined a policy and legal framework for biosimilars. Absence of such regulation and biosimilars approval process in other countries, in particular in the United States, has led to a competitive advantage for the EU biosimilars industry. This process began in 2003, with the introduction of the concept of biological similarity in the EU legislation. Subsequently, the Pharmaceutical Directive was issued, establishing the pathway for approval of biosimilars in Europe. Biosimilars are evaluated by the European Medicines Agency (EMEA). EMEA is the centralized scientific body of the European Commission responsible for the assessment of medicines, including biosimilars. Medicines approved through Europe’s centralized procedure go through a two-step process: EMEA’s regulatory review is completed when its Committee on Human Medicinal Products (CHMP) issues a positive opinion; the EC then grants the final marketing authorization. EMEA was also given a pivotal role in the implementation of the regulatory framework for biosimilars in Europe by delegating responsibility for its implementation to the experts at EMEA. This included responsibility to develop published regulatory guidelines specific to biosimilars. EMEA has issued a number of overall guidelines on biosimilar describing the general data necessary for biosimilars, as well as product-specific guidelines on biosimilar versions of recombinant human insulin, human granulocyte-colony stimulating factor, recombinant human growth hormone, erythropoietin, and low molecular weight heparins.

Research incentives were established by prohibiting filing of any generic drug or biosimilar application for eight years after the originator is approved, it then precludes approval of these competing medicines for an additional two years. That 10-year period can be extended to 11 years of a clinically significant new indication is approved for the innovator with the first eight years after it is approved. This is generally referred to as the 8+2+1 exclusivity provision.