US curb on Indian biopharma firms

Indian biopharmaceutical companies are likely to face more hurdles in the US. This is on the back of the US Senate Health, Education, Labour & Pensions Committee approving an amendment that will protect biotech developers from generic competition for 12 years. Though the amendment is yet to be approved by the Congress, if it is passed in its current form, will deal a huge blow to Indian companies engaged in research and manufacture of biosimilar drugs. Biosimilar drugs are similar versions of biotech drugs, akin to generics being copies of chemical drugs.
Sujay Shetty, Associate Director, PricewaterhouseCoopers, said, “Biotech companies wanted protection for 14 years while President Obama was more inclined towards a 7-year protection. Congressman Henry Waxman wanted protection to be granted only for 5 years. A 12-year protection from generic competition will be disappointing for Indian companies, as it delays access to the US market.”
Dhananjay Patankar, Chief Technical Officer, Intas Biopharmaceuticals, remarked, “The shorter the protection period, the better for us. Once a patent is filed, it takes a company almost 10 years to develop the product and reach the market. The company then has another 10 years to derive returns from its drug, when generic competition is negligible. Added protection means that for any patent which is filed this year, it will be almost 22 years from the date of filing the patent that a generic company can hope to benefit from it.”  Villoo Morawala Patell, Avesthagen CMD, however, sees this as a positive step. “Earlier there was no clarity on the guidelines. Now there is clarity which will help Indian companies in raising funds from investors. Indian companies are targeting 12 protein and monoclonal antibody drugs that are scheduled to go off-patent by 2020, and which have a market of $40 billion.”

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