Biocon’s biosimilars withdrawn in EU

Shares in Biocon have fallen after the company withdrew two filings for biosimilars in Europe because of ongoing concerns over its manufacturing facility.

The company said the withdrawal of its Herceptin (trastuzumab) and Neulasta (pegfilgrastim) biosimilars were regulatory requirements after EU authorities wanted to re-inspect manufacturing facilities in Bangalore.

Just over a month ago, it emerged that EU regulators required “corrective and preventive” actions at the plant before it is able to supply drugs to the EU market.

Inspectors from the French regulator had been conducting a pre-approval inspection of the plant, which produces biosimilars of Herceptin, Neulasta and Sanofi’s Lantus (insulin glargine).

But although they approved the facilities they required the undisclosed issues to be addressed.

The re-inspection’s findings will be considered by the European Medicines Agency’s CHMP scientific committee.

Corrective and preventive actions will be completed by the end of this quarter and Biocon hopes to ask for a re-inspection once they are complete, followed by a refiling.

Biocon and partner Mylan became the first companies to file a biosimilar of Roche’s big-selling breast cancer drug Herceptin (trastuzumab) in the EU last summer, shortly after filing a biosimilar of Amgen’s long-lasting white blood cell booster Neulasta (pegfilgrastim).

The delays mean that the cheaper Herceptin competitor will be significantly delayed – the EMA typically takes just over a year to approve a drug, meaning the biosimilar could have been launched this autumn without the regulatory issues as Herceptin is off-patent in the EU.

Biocon has given no indication about how long the new review will take.

The announcement also sparked speculation about Mylan and Biocon’s hopes of getting the drug approved in the US.

Although an FDA panel unanimously recommended the Herceptin biosimilar last month, there are concerns that the EU regulator’s findings could affect the outcome of the US regulator’s review.

 

 

 

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