WITH pharma biggies like Ranbaxy and Dr Reddy’s Lab announcing plans to tap the regulated biotech drug market, mid-sized players in the segment are harbouring such ambitions.

Hyderabad-based mid-sized biotech firm Bharat Biotech International is finalising plans to roll out drugs in Europe and US. For starters, the company will initiate European trials on three products which will be soon filed to the European Medicines Agency (EMEA) for regulatory approval. It is also in talks with a couple of US pharma companies to enter into a technology and marketing partnership.

Elaborating, Bharat Biotech International chairman and managing director Krishna M Ella said the company intends to carve out a niche in the wound care segment for Europe and US.

“We will commence regulatory filings over the next six months,” he said.

The company has plans to launch its blockbuster product ‘Regen-D’ in Europe. The drug is India’s first recombinant human epidermal growth factor (rhEGF) which is used for treatment of diabetic foot ulcers, burns and skin grafts. However, the company declined to give the name of the other two drugs shortlisted for Europe.

“The Phase III and post-marketing surveillance data for Regen-D has been recently published in noted journal ‘Wounds’. We will also develop a fresh set of Phase III trial data for drugs in Europe. This will facilitate the regulatory process,” said Mr Ella.