CMC data issues at Biocon plant prompt US FDA to reject Neulasta biosimilar

By Dan Stanton contact

- Last updated on GMT

GettyImages/fruttipics
GettyImages/fruttipics
Mylan and Biocon have received a complete response letter for a version of Amgen’s Neulasta (pegfilgrastim) in the latest regulatory blow to their biosimilar ambition.

In February​, Mylan and Biocon announced the US Food and Drug Administration (FDA) had agrred to review their regulatory application for MYL-1401H. But yesterday the firms said the molecule – a proposed biosimilar to Amgen’s Neulasta (pegfilgrastim) – was rejected in a complete response letter (CRL) issued by the Agency.

“The CRL relates to the pending update of the BLA with certain CMC [chemical manufacturing control] data from facility requalification activities post recent plant modifications,”​ Biocon said in letter filed with the Bombay Stock Exchange​.

The US FDA issues a complete response letter when it wishes to communicate to a company that an application to market a drug (NDA, new drug application) will not be approved in its present form.

It also indicates that the review of the application by the FDA has been completed.

“The CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamics data, clinical data or immunogenicity.”

The news comes 15 months after​ the FDA rejected a version of Neulasta made by Novartis subsidiary Sandoz.

GMP violations

The collaboration between Mylan and Biocon focuses on the development and commercialisation of six biosimilar products. Under terms of the partnership, Biocon is charged with manufacturing the products from its bioproduction facilities in Banagalore, India.

Biocon suffered a setback in March​ when European regulators found 35 GMP deficiencies – eleven deemed “major”​ – at the fill/finish facility.

France’s ANSM recommended biosimilar versions of Neulasta, Roche’s Herceptin (trastuzumab) and Sanofi’s Lantus (insulin glargine) made there “should not be approved while this NCR is in force,” ​and no batch manufactured prior to the issuance of the report “should be supplied to Europe.”​​

And the site was also subject to an FDA inspection in May and June​, resulting in a Form 483 with 10 deviations. Biocon and Mylan later announced the FDA had pushed back the target action date for their trastuzumab biosimilar application by three months, but said this was “not related to any cGMP audit observations made by USFDA at our manufacturing facilities​.”

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