Germany’s Biosimilar Policies

28 November 2018

Germany’s Health Minister, Jens Spahn has called for the faster adoption of cheaper copies of biotech drugs to cut the cost of healthcare in Germany.

In recent years, biotechnologically produced drugs have become a significant driver of drug spending in Germany, with 6.7 billion Euro in Statutory Health Insurance (SHI) funds spent on the treatment of rheumatic diseases alone between January and September 2018. Biosimilars are recognized as a way to contain such costs.

The National Association of SHI accredited Physicians recommend quotas for biosimilars to improve prescription uptake, with the SHI providing incentives to physicians to prescribe biosimilars through quotas, budgeting, and monitoring programs.

With quotas being difficult to manage in Germany, Spahn favors a policy based on price, requiring pharmacists to deliver the cheapest biosimilar,  in a similar way as generics are dispensed. If consistent use of biosimilars were enforced, the health ministry has estimated that this would have saved the healthcare system 279 billion euro in 2017. Projected savings are expected to rise due to many expiring patent protections for several biologics in the coming years.

Details of the proposal will be issued in the revision of the German Medicines Act (AMG), which was presented as a draft earlier this month.  This move once again demonstrates the cost-oriented approach of the governments’  health policy, which is seconded by both providers and health insurance funds.

New developments across Germany’s healthcare industry provide significant opportunities for global innovators, however many hurdles and barriers to entry still exist. If you are interested in learning more about gaining access to Germany’s healthcare market, please contact us.