FDA Proposal Set to Cut Biocon's Biosimilar Development Costs by Half: Impact on Global Healthcare Access

Biocon's biosimilar revenue witnessed a 25% growth in the most recent quarter.

India-based Biocon anticipates a 50% reduction in the development costs for complex biosimilars following the United States' proposal to simplify clinical testing requirements for these drugs, which constitute over 60% of the company's revenue, according to a senior executive statement on Wednesday.

Biosimilars are alternatives to expensive biological drugs used for treating serious conditions including cancer, rheumatoid arthritis, psoriasis, and diabetes. Last month, the U.S. Food and Drug Administration proposed streamlining drug testing by reducing the need for extensive comparative clinical efficacy trials.

Biocon, which plans to launch a total of 20 biosimilars by 2030, is currently prioritizing upcoming product introductions in the strategic markets of the US and Europe, explained Shreehas Tambe, CEO of Biocon Biologics, a Biocon subsidiary, during an interview.

"You can do more because it's (FDA's draft proposal) going to halve the cost of development... you can develop them (biosimilars) and bring them to patients faster and make it more affordable."

With seven biosimilars already available in the U.S. commercial market, Biocon aims to introduce two additional products within the next six months. The company's oncology biosimilar medications currently hold a quarter of the U.S. market share and will benefit significantly from reduced development costs, according to Tambe.

The company reported a 25% growth in biosimilar revenue during the latest quarter.

Additionally, Biocon is seeking to broaden its generics segment by introducing weight-loss drugs to drive future growth, as previously announced by the company.