September 2019 has proven a challenging month for global generics firm Mylan. The company received their second CRL, a communication from FDA that they have reviewed a drug application and will not approve it in its current form, for their insulin biosimilar.

Mylan have developed the insulin glargine product with Indian pharmaceutical company Biocon. The biosimilar is called Semglee and aims to rival Sanofi’s blockbuster drug Lantus, which is the most prescribed long-acting insulin product.

The CRL identified 12 deficiencies at Biocon’s insulin manufacturing facility in Malaysia during an inspection in June 2019. Although FDA did not identify any outstanding scientific issues with the application, they have called for Corrective and Preventive Actions (CAPAs).

A Biocon spokesperson said: ‘We remain confident of the quality of our application and do not anticipate any impact of this CRL on the commercial launch timing of our Insulin Glargine in the US. We remain committed to global standards of Quality & Compliance and are working closely with our Partner and the regulator to complete these CAPAS to the satisfaction of the US FDA’.

This follows a previous CRL for Semglee in June 2018, associated with a change in manufacturing site from Bangalore to Malaysia. The drug has been approved in Europe and is already launched on the UK market.

Biocon also revealed that four observations had been made during a current good manufacturing practice (cGMP) inspection of one of their Biologics Drug Product facilities in Bangalore. The company say: ‘… we believe [these observations] will not impact supplies from this facility. We are confident of addressing these observations through a Corrective and Preventive Action plan in a timely manner’.

In more positive news for Mylan, the company has recently settled a patent infringement case with Amgen over their pegfilgrastim biosimilar Fulphila.

Pegfilgrastim is a filgrastim analogue which is used to stimulate the production of white blood cells in chemotherapy. It has been sold in the US by Amgen as Neulasta, where it can fetch over US$15,000 per dose.

Fulphila was approved by FDA in June 2018 and launched soon after. However, Amgen claimed Mylan’s patent used similar ‘washing’ and ‘eluting’ claim language.

However, in submitting their stipulation to the District Court, the parties agreed that Mylan’s patent does not infringe on Amgen’s, thus resolving the dispute between the two companies.

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