biosimilar – Page 2

November 12, 2018

See generics business ramping up significantly over the next 2-3 years, says Biocon

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Biocon is expecting generics business to contribute significantly to overall revenue over next 2-3 years, said Kiran Mazumdar Shaw, CMD of the company.

Shaw said that Bengaluru plant is going to be used for generics business.

Talking about biosimilar, she said, “We have recently finished a drug substance inspection and did not get any 483 (is a form used by the FDA to document and communicate concerns discovered during these inspections.), so that was also a very welcome outcome.”

We are fairly confident of achieving biosimilar revenue guidance, added Mazumdar Shaw.

June 1, 2018June 5, 2018

USFDA to give observations on Biocon’s Pegfilgrastim drug on June 4

By June 4, US Food and Drug Administration (FDA) will give their opinion on Biocon-Mylan’s application for biosimilar Pegfilgrastim.

The drug is used in US for building white blood cells in cancer treatment. The US market size of Pegfilgrastim is $3.9 billion.

A biosimilar drug is the most similar version of an existing drug while a generic drug is an exact copy of an existing drug.

A biosimilar is only the closest version of a biologic drug as they are made from living organisms such as yeast or proteins and hence cannot be exactly replicated like the chemical structure of generic drugs.

About 30% of drug sold globally currently are biopharma drugs. In the US alone, 40% of prescription drugs spending is on biologic drugs.

It is the second application by Biocon with regards to the biosimilar space.

If USFDA gives nod for Pegfilgrastim, it will be the second biosimilar that Biocon has received an approval in couple of months.

Earlier, USFDA had issued a few observations on Biocon’s Bangalore facility in a pre-approval inspection, which had taken place a couple of months ago.

Remain focused on companies with exposure to Indian markets, says India Infoline

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

watch full video of Abhishek Sharma with CNBC-TV18.

India Infoline, a financial service firm issued a report on pharmaceutical companies, specifically analyzing US business margins.

The report suggested that there has been a 1,200 bps kind of a margin erosion for Indian companies which are serving the US generic markets as a whole. Out of that, half of the margin erosion has come because of the price pressure and the other half has come because of the increased R&D activities.

“We essentially remain focused on companies which have a higher share of EBITDA coming out of India and other markets as compared to US where we still see challenges going forward in terms of pricing pressure continuing”, said Abhishek Sharma, Vice President and Pharma Analyst at IIFL.

“On that parameter, we would essentially like companies like Torrent and Alkem Labs, which still continue to derive a lion share of their EBITDA from this market”, he further added.

Sharma also stated that Biocon has efficiently played out in the last one to one and a half years.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter