Intas Biopharmaceuticals Limited (IBPL) and Canada-based Apotex Inc have extended their business agreement to develop a biosimilar version of pegfilgrastim, a protein that is used to treat neutropenia, a side effect of cancer chemotherapy. Neupeg, a recombinant pegylated granulocyte colony stimulating factor is already manufactured and marketed in India and other countries by IBPL.

Both companies, IBPL and Apotex are eying a significant share of total Peg GCSF market in North America, which is currently estimated to be around $3.5 billion annually. This collaboration gives Apotex the rights to market the product in North America (US and Canada), Europe and selected other countries. After announcing launch of first GSCF generic for North America in May 2008, the extension of collaboration between the two companies makes IBPL the first Indian biopharmaceutical company to announce the launch of Peg GCSF for North America and European markets.

Apotex, one of the largest generic pharmaceutical companies in the world, has a strong registration, marketing & distribution team while IBPL, being a quality driven organization, offers a unique competitive advantage in terms of R&D and manufacturing of biopharmaceuticals. The deal offers immense growth opportunities for both the companies as they look to consolidate their presence in the global bio-similars market. With changing political and diplomatic scenario in US, both the companies expect speedy implementation of legislation related to bio-similars, which is much awaited development from industry fraternity across the globe.

According to Dr Jeremy B Desai, Apotex executive vice president, Research & Development, "This agreement represents an important milestone for Apotex, as it continues to build the organization's bio-similars pipeline."

"This agreement is a step forward to the vision that we all work for - to become a global biopharmaceutical company. This will provide accessibility of Neupeg to people outside of the subcontinent, who are currently relying heavily on innovator's brand and other substitutes," stated Mani Iyer, executive director, Intas Biopharmaceuticals Limited.

As far as Pegylated Filgrastim is concerned, IBPL is the only biopharmaceutical company to manufacture it in India and market the same under the brand name Neupeg. In India, the brand is a blockbuster drug and IBPL is looking to replicate the success of the brand in North America and Europe.