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Amgen appeals over orphan drug biosimilar ban

Vials of liquid on a white table and the logo of a large pharmaceutical company.

Alexion obtained a preliminary injunction in Munich barring Amgen from selling a biosimilar version of its antibody drug

Amgen has appealed against a German court order issued last Friday, August 4, after having earlier been forced to pull a drug for a rare blood disorder from the German market.

Alexion, a UK-based biologics developer owned by AstraZeneca, asserted orphan drug exclusivity (ODE) rights on its antibody treatment Soliris (eculizumab) against Amgen at the Munich Regional Court earlier this year.

Soliris is approved by the European Medicines Agency (EMA) to treat paroxysmal nocturnal haemoglobinuria (PNH), a chronic blood condition, as well as other rare diseases.

The EMA approved Bekemv, Amgen’s biosimilar version of Soliris, for the treatment of PNH in April this year, after Alexion’s monopoly on that use of the drug expired.

But in May, days after Bekemv launched in Germany, Alexion obtained a preliminary injunction at the Munich court that restricted Amgen’s sale of the drug.

Alexion claimed there was a risk that Bekemv would be used for the off-label treatment of conditions other than PNH, for which Alexion still has exclusive rights.

Soliris is protected by ODE until later this year for atypical haemolytic uraemic syndrome, until 2027 for generalised myasthenia gravis, and until 2029 for neuromyelitis optica spectrum disorder.

The Munich court upheld May’s preliminary order last Friday, August 4, after finding that Amgen had contributed to the risk of off-label use of Bekemv by sending letters of recommendation to medical practitioners.

A spokesperson for Alexion said: "We are pleased with the court’s decision in that it helps protect some of the incentives that propel innovation in the rare disease space.”

Counsel for Amgen said the case was the first time the holder of ODE rights had asserted them against a competitor in Europe.

The court ruled Amgen couldn’t market Bekemv unless it met certain conditions, which its lawyers have described as “unreasonable” and “unbearable”.

Amgen, represented by Osborne Clarke and Bardehle Pagenberg, has appealed against the decision to the Federal Court of Justice.

According to Tilman Müller-Stoy, partner at Bardehle Pagenberg, the injunction is based entirely on the mere danger of off-label use.

The court’s order would require Amgen customers, including hospitals, to contractually agree not to make any off-label use of the drug, Müller-Stoy said.

Alexion has also sued Samsung’s biosimilars unit, Samsung Bioepis, at the same court. A hearing over a preliminary injunction in that case is scheduled for August 16.

The EMA approved Samsung Bioepis’s biosimilar version of eculizumab in May.

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