No surprise: FDA hits Mylan and Biocon with CRL for their follow-on copy of Lantus

The FDA has issued a complete response letter to partners Biocon and Mylan for their version of Sanofi’s blockbuster Lantus insulin, a development they say came as no surprise. Three months ago, the agency noted issues at the manufacturing site where it is produced.

A Mylan spokesperson acknowledged the CRL in an email Tuesday, saying the company has figured the delay into their launch plan for the product.

“Following submission of our Insulin Glargine application under the 505(b)(2) regulatory pathway, we had agreed with FDA to provide additional clinical data in support of the manufacturing site change from Bangalore to Malaysia. Hence, the recent CRL was anticipated and built into our plan."

The so-called “follow-on insulin glargine,” which references Lantus, has already been approved in Europe under the trade name of Semglee, but the partners have yet to satisfy the FDA that the manufacturing is all in order.

RELATED: Plant where Biocon and Mylan will produce their Lantus copy spanked with FDA Form 483

The partners in late February announced the FDA had issued a Form 483 with half a dozen observations during its first inspection of the Biocon plant in Malaysia where the insulin will be produced. Biocon said at the time that corrective actions were already underway.

That action was actually the second manufacturing glitch the partners have run into in their effort to get a Lantus copy to the U.S. market. The FDA issued a Form 483 last year for Biocon’s plant in Bangalore, India, where it makes the autoinjectors for its insulin products. It took about six months, but Biocon was able to get those issues resolved.

RELATED: Sanofi sues Mylan over Lantus patents, seeking to defend its top-selling drug

The CRL action is a break for Sanofi. Even though sales of Lantus have declined precipitously as the drugmaker has cut prices to compete, Lantus remains Sanofi’s top-selling product. All told, Lantus sales in the U.S. dropped 28.7% to €498 million ($602 million) during the first quarter. That caused worldwide sales of the product to fall 13.5% to €1,108 million ($1.3 billion).

The French drugmaker is not going to let those billions of dollars in sales go unchallenged. Sanofi last fall sued Mylan claiming the U.S. drugmaker has infringed 18 of its patents with its Lantus follow-on.

RELATED: Amgen's $3.9B Neulasta to face U.S. biosim 'in the coming weeks' with Mylan approval

The CRL disclosure came the same day that Mylan and Biocon had good news to announce. They have received FDA approval to launch a biosim to one of the biggest drug targets in the U.S. market. Their biosimilar of Amgen's Neulasta, a drug that banked $3.9 billion in U.S. sales last year, will be launched shortly, they said.