The German biotech sector lags behind in the development of novel gene therapies

Is Germany keeping pace with the latest biotechnological development trends? According to the Association of Research-Based Pharmaceutical Companies, or vfa bio, there is a need for action.

Within a decade, the share of recombinant drugs in the German pharmacy and hospital market has almost doubled and the manufacturer’s turnover has almost tripled. In 2019, the market share of red biotechnology was 29 percent (2009: 16 percent) with total sales of $14.3 billion (€12.7 billion) (+13 percent, at ex-factory prices). That was reported by Dr. Frank Mathias, Chairman of the vfa bio interest group, in Frankfurt on Tuesday, June 30th. 

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Germany should involve more in the research and development of novel gene therapies 

According to the report, biosimilars, which exceeded the billion euro mark for the first time, grew disproportionately strongly in the year under review – and with $1.68 billion (€1.5 billion) in manufacturer sales they did so significantly (+60%).

The biotech industry is also attracting particular attention due to the recent approval successes of novel gene and cell therapies, which are summarized in industry jargon as “Advanced Therapy Medicinal Products” under the abbreviation ATMP. Ten such therapies have been approved in the EU since 2015, and many more are expected to follow. According to the Boston Consulting Group (BCG), more than 1,000 phase I to III study projects worldwide are working on new gene or cell therapies.

“Do we want to participate or leave it to others?” said Dr. Frank Mathias, Chairman of vfa bio. A rhetorical question on the promotion and testing of new gene and cell therapies in Germany.

Mathias cited the coagulation factor IX replacement therapy Fidanacogen Elaparvovec, which is currently being tested by Pfizer and Spark Therapeutics in phase III, as an example of one of the next innovations in this field. Spark, as the developer of the gene therapy Luxturna (Voretigen Neparvovec, together with Novartis), is one of the pioneers of the ATMP.

According to Mathias, Germany is not yet particularly well positioned in research and development of novel gene and cell therapies. Most studies are carried out in the USA (48%) and China (39%). 

Although Germany ranks third, this does not make an impression given that only around four percent of all clinical ATMP projects are carried out in Germany. Among the recommendations that vfa bio makes to Berlin in order to trim the location to an, so literally, “ATMP welcome culture” are: to establish a research center for gene and cell therapies modeled on the DKFZ, to establish an “ATMP Task Force” to harmonize the requirements for clinical trial projects across countries, and to provide the Paul Ehrlich Institute with more staff in order to shorten the approval period for clinical studies.

In addition, the use of these innovative therapies must be reimbursed to the clinics more quickly. The current option of agreeing on additional fees for “new examination and treatment methods” (NUB) is too cumbersome and restrictive.

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(Featured image by qimono via Pixabay)

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