Biosimilars in Germany: Guidance of the Drug Commission of the German Medical Association

Category: Perspective
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Biosimilars (biosimilar medicines) have been available in Europe for more than ten years, which has made it possible to gain practical experience with these products, particularly in oncology, rheumatology and gastroenterology.Nevertheless the adoption of biosimilars in Germany has not been very successful and still faces many concerns voiced by physicians about their pharmaceutical quality, efficacy (particularly in extrapolated indications), safety (especially immunogenicity) and interchangeability with the originator product (1). These misconceptions cannot be explained medically or scientifically. The uptake of biosimilars in Germany has not been very high to date, as no approved biosimilar has achieved complete or at least high market penetration, even after ten years of availability (2).

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