(Reuters) -The U.S. Department of Health and Human Services will hold a public conference on Wednesday to outline plans for accelerating the approval of biosimilars or generic versions of complex biological drugs, as part of a broader push to expand access and cut healthcare costs. The move comes despite lobbying efforts from major pharmaceutical companies […]
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US health department to host event on plans to reform biosimilar development
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(Reuters) -The U.S. Department of Health and Human Services will hold a public conference on Wednesday to outline plans for accelerating the approval of biosimilars or generic versions of complex biological drugs, as part of a broader push to expand access and cut healthcare costs.
The move comes despite lobbying efforts from major pharmaceutical companies and industry groups, which have argued that easing requirements could hurt innovation and limit treatment options.
The Financial Times, which reported on the news earlier on Wednesday, said the U.S. FDA is expected to reduce the number of human clinical studies required for certain biosimilars and cut development costs for medicines made using living cells.
The HHS event is scheduled to begin at 1:00 pm ET, according to its website.
Biological drugs are the fastest-growing class of medications in the United States and account for a substantial and growing portion of health care costs, the FDA has said.
Biosimilars have faced multiple barriers to uptake, including physician hesitancy, payer policies, and complex patent litigation.
Drugmakers such as Eli Lilly, Pfizer, Merck and Bristol Myers Squibb have warned investors about the impact of biosimilar competition in regulatory filings, while generics makers including Teva, Dr Reddy’s and Sandoz have supported reforms.
The FDA’s reported move follows recent pricing agreements between U.S. President Donald Trump and drugmakers, which have added pressure on branded drug revenues.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shailesh Kuber)