At least two Indian drugmakers — Natco Pharma and MacLeods Pharmaceuticals — are ready to bring out their versions of Johnson & Johnson’s breakthrough Tuberculosis (TB) drug, Bedaquiline.
The J&J drug is the first for TB to be globally approved in about 40 years, and is less toxic and more effective than traditional treatments. A key patent on the drug expires this July.
In fact, late last month, the Indian Patent Office had refused J&J’s application for a secondary patent on the salt form of the drug, that could have come in the way of generic drugmakers making less expensive versions of the drug. The development was in response to a pre-grant challenge brought on by two patients.
A Macleods spokesperson confirmed to businessline that they are ready to commercialise the drug in India once the patent expires. The product already has an ERP (Expert Review Panel) approval from the Global Fund, the official added. The Global Fund panel comprises independent experts who review the drug’s potential risks and benefits before recommending its use.
An ERP approval is possible only after the company has applied for a World Health Organization pre-qualification (PQ) and technical details are submitted, an industry-insider explained. Getting a WHO PQ will further pave the way for the product to be picked up by more countries for their TB programmes.
An industry-insider confirmed that Natco too was making both the Active Pharmaceutical Ingredient (API) and finished dosage form of Bedaquiline. It was in the process of getting other regulatory clearances, given the special nature of the drug, an industry-representative said.
While the timeline for the local launch of both drugs is not clear, it will help bring down the price on the innovator drug. It is expected that more companies, including those that have a TB drugs portfolio could venture into this product - but they are keeping their cards close to their chest.
J&J stood by its position taken since the patent-challenge ie the patent application for a formulation of bedaquiline was filed in India over a decade ago, as part of standard procedure. Its patent status notwithstanding, generic manufacturers would not have been prevented from developing the active pharmaceutical ingredient (API) after July 2023 when J&J’s API patent expires in India, it maintained.