Generics and biosimilars should go faster

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Frankfurt, BerlinGerman manufacturers of generics and biosimilars need a lot of patience so far. The production of such copies of medicines may not start in Europe until all patent rights have expired. The European Parliament has now relaxed the strict EU patent law this Wednesday. In three years' time, companies should be able to start producing counterfeit medicines earlier, both for export to third countries and for entry into the European market.

While original manufacturers warn of erosion of patent law, generics companies are happy. The project "greatly facilitates the conditions for planning and production of market launches," says Miguel Pagan, Global Production Director of Stada. In addition, the amendment to the law improves the competitiveness of sites within the EU.

"For generics and biosimilar companies, it is enormously important to be the original drug in the German market on the first day after patent expiration with a generic or biosimilar," says Christoph Stoller, CEO of Ratiopharm manufacturer Teva in Germany and Austria. That is currently the case regularly.

"However, in order to facilitate this important early market entry, we are currently forced to move to other manufacturing locations in countries where, from a patent point of view, the generic drug is already allowed to be produced. This competitive disadvantage will no longer exist after this positive new regulation, "said the German boss of the world's largest generics company.

The vote in the European Parliament scheduled for this Wednesday was a matter of formality. As early as mid-February, negotiators from the European Parliament, the European Commission and the European Council agreed on a compromise, which introduced new rules for the so-called supplementary protection certificates (SPCs).

These certificates enable pharmaceutical companies to obtain market exclusivity in the EU for up to five years after the usual 20 years of patent protection for their original medicines. The additional deadline is intended to compensate for lengthy test phases and pre-market trials.

The new EU regulation allows European generics manufacturers to start production for export to third countries during SPC protection. They will also be able to produce the drug copies for market entry in Europe six months before the end of the protection certificate.

The prerequisite is that the companies inform the original manufacturer and the patent authorities about the plans. The new regulation should take effect from July 2022.

Criticism from the original manufacturers

"We are eliminating a major competitive disadvantage for EU producers, who will soon be able to compete on the highly competitive world markets on equal terms," ​​EU Industry Commissioner Elzbieta Bienkowska said after the agreement in February. In Germany alone, the generics industry generates sales of almost six billion euros.

The commission expects the industry across Europe with a sales increase of at least one billion euros annually through the new export opportunities. Within ten years, up to 25,000 additional pharmaceutical jobs could be created in the EU.

The original manufacturers, however, see the plans very critically. "The EU is home to many strong research-based pharmaceutical companies. Their commitment and their high investments are directly linked to the protection of intellectual property, "said Birgit Fischer, chief executive of the Association of Research-Based Pharmaceutical Companies.

Therefore, together with the European pharmaceutical association EFPIA, we strictly reject any restriction of patent protection. "That would be an industrial policy hit for one of the most vital sectors of our continent," said Fischer.

The pharmaceutical company Boehringer Ingelheim also warns: "The weakening of intellectual property protection in Europe runs the risk of reducing investment in the risky and costly R & D of pharmaceuticals, to the detriment of employment and growth."

Innovative medicines of today are generics and biosimilars of tomorrow. The reduction of innovation incentives therefore also a pity the future of patent-free drugs, said a spokesman for the pharmaceutical manufacturer.

Boehringer Ingelheim also produces biosimilars themselves, ie counterfeit products of biotechnologically produced drugs. The company could theoretically benefit from the new regime. However, the company decided in 2018 to push forward its biosimilar activities, including opportunities for partnerships, out of the US market, according to the spokesman.

The generics companies operating in Germany expect to strengthen their local locations. So far, the SPC regulation has led to "that development and production capacities are systematically relocated from Germany – with noticeable consequences for the production site Germany," said a spokeswoman for the Berlin-based generic drug company Aristo Pharma with more than 1200 employees.

Only in the rarest of cases will the production, which is often started in Asia, be postponed after the protective rights expiration, because this would be associated with enormous financial and organizational effort.

Pharmaceuticals (t) Pharmaceutical companies (t) Generic (t) Biosimilars (t) European Parliament (t) Teva (t) Stada (t) Ratiopharm (t) Boehringer Ingelheim (t) EFPIA (t) Birgit Fischer (t) pharmaceutical industry

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