SEC recommends permission to Biocon to
import and market insulin aspart
injection

The expert panel advising the drug regulator on approvals has recommended grant of permission to import and market Biocon Biologics’ insulin aspart injection with waiver of phase III clinical trial in the country with certain conditions.

The firm presented proposal for import and marketing of the drug with waiver of phase III clinical trial in the country. It has also presented detailed proposal along with chemicals, manufacturing and control (CMC), pre-clinical and clinical trial data.

The Subject Expert Committee (SEC) met in Delhi on May 18, noted that the firm has conducted phase I and phase III trial with the drug in Germany and USA respectively and based on the results of the trial, the drug has been granted marketing authorization by EMA and Health Canada.

Biocon Biologics also said that its biosimilar insulin aspart has received regulatory approvals in developed markets like EU and Canada and emerging markets like Malaysia.

After detailed deliberation, the committee recommended for grant of permission to import and market the drug with waiver of phase III clinical trial in the country with the condition that firm should conduct phase IV clinical trial in India as per existing guidelines in the country.

The clinical trial also includes a sub-set population to generate PK/PD and immunogenicity and submit the protocol to Central Drug Standard Control Organisation (CDSCO) before placing the drug in the market.

The company, in February 2021, announced that Kixelle, a biosimilar insulin aspart co-developed with Viatris Inc., has received marketing authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

Kixelle, a fast-acting insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents and children aged one year and above, has been approved as a 100 units/ml solution for injection in vial and pre-filled pen presentations. According to reports, it is a biosimilar of Novo Nordisk’s brand Novolog.

In January, 2022, the company said that the US FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for insulin aspart filed by its partner Viatris (Mylan).

“We will respond to the CRL to satisfy the FDA’s requests. The CRL did not identify any outstanding scientific issues with the product,” said a company spokesperson during then.

On February 28, this year, the company announced that it will acquire Viatris’ Biosimilars Assets for up to $3.335 billion in Stock and Cash.

Biocon Biologics will realise full revenues and profits from this business and will gain Viatris’ global biosimilars business whose revenues are estimated to be $1 billion next year, along with its portfolio of in-licensed biosimilar assets, the company said during the time. The transaction accelerates BBL’s direct commercialisation strategy for its current and future biosimilars portfolio, it added.

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