Biosimilars are an established part of the pharmaceutical market

18.07.2023 14:56

The number of biotechnologically produced medicines on the German market is growing continuously: 37 biopharmaceuticals – 30 of which were original products and 7 biosimilars – were added last year. This means that 398 biopharmaceuticals are now approved for the German market, reports the Association of Research-Based Drug Manufacturers (vfa) in its current biotech report.(1)

The copycat preparations of biopharmaceuticals, which can be developed after the patent of the original preparations have expired, are now a fixture on the pharmaceutical market: not only are their numbers constantly growing, but their market share compared to original biopharmaceuticals is also increasing from year to year. “The positive development of biosimilars clearly shows that a regulatory
Political intervention is completely unnecessary,” says Manfred Heinzer, Managing Director of Amgen GmbH. “If automatic substitution is introduced in pharmacies in August, it will bring more uncertainty than effect.”

Last year it was once again shown that biosimilars can successfully compete against original products in the corresponding biopharmaceutical segment. They achieved an average share of 64 percent. This is an increase of four percent compared to the previous year. Some of the biosimilars even achieve market shares of up to 80 percent in the first year after their introduction in competition with original products. “The vfa figures prove that the combination of patent-protected original products and biosimilars works very well – even without political intervention and without introducing pharmacy substitution,” comments the Amgen managing director.

The biotech manufacturer Amgen also decided to develop biosimilars years ago. The company today has 15 original products and three biosimilars on the German market. “We are developing both in the therapeutic areas of oncology, hematology and inflammation; “This is how we enable access to innovative therapies for many people,” says Heinzer. “At the same time, biosimilars relieve the financial burden on our healthcare system.”

Medical innovations against cancer

Many biopharmaceuticals are used in cancer therapy. Oncology is also a development focus in research. The entire pipeline currently includes 672 research projects - of which, according to the vfa Biotech Report, 302 projects are looking for new therapeutic approaches against cancer. Some of these projects are being researched at Amgen Research (Munich) GmbH. The research center specializes in the innovative BiTE® (bispecific T cell engager) technology and is working on this immuno-oncological approach in both hematological and solid tumors
to use.

The well-filled pipeline shows that pharmaceutical companies continue to invest in research and development at a high level. Amgen, for example, spent $4.4 billion on global research projects last year, or 17 percent of its sales. “Medical innovations cannot be taken for granted,” emphasizes Heinzer. “They are the result of a lot of work, but also of high and risky investments, because a high proportion of the projects do not make it past the research stage. Such investments require reliable framework conditions – politicians have a duty here if they want to maintain Germany as a research location.”

credentials

1. Biotech report “Medical biotechnology in Germany 2023”, Boston Consulting Group, Association of Research-Based Drug Manufacturers eV