Biocon and Mylan: The Race to Approve Insulin Glargine Follow-on

Biocon received a second complete response letter relating to manufacturing plant problems in Malaysia. This may seem like a straight forward issue that could hamper its efforts to produce an insulin glargine follow-on agent, but it can become a major problem barring a very quick resolution.

In the filing Biocon made to the India Stock Exchange, the company said, “The CRL did not identify any outstanding scientific issues with the application. 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.” However, that may be a fairly optimistic opinion.

Insulin copies are part of the class of biologics designated “transitional products” that will be approved only through the 351(k) biosimilar approval pathway after March 2020. The latest rules issued by the Food and Drug Administration (FDA) specify that if a product in this drug class (and others like growth hormones) does not receive approval by this date, the manufacturer must submit an entirely new biologic licensing application (for approval as a full-fledged biosimilar). That would require completing all of the necessary developmental steps—proving the physiochemical and pharmacodynamic equivalence to what would now be termed the reference product—Lantus®.

The FDA rules for transition products do not exempt agents that have already received complete response letters and may still be in the FDA’s queue. This is relevant because neither of Biocon’s rejection letters (the first issued in June 2018) pointed to problems with the scientific evaluation of its insulin glargine. Rather, both involved failed inspections at the plants at which Biocon was going to manufacture the agent. The drug was approved by the European Medicines Agency and is currently available by prescription in the EU.

As indicated in a previous post, pharmaceutical company interest in insulin biosimilars is fairly low. That may be because of the approaching transition date.

The question remains, can Biocon correct its Malaysian manufacturing plant deficiencies, can FDA reinspect, and can FDA issue final approval for this 505(b)2 agent before February 29, 2020? If not, even if Biocon’s plant passes inspection in December 2019, that will likely result in years’ long delay before the new BLA can be submitted.

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