Celltrion said Friday it will immediately apply newly eased US biosimilar development rules to its pipeline, a move expected to cut development costs and shorten timelines.
The decision follows the recent release of the fourth revision of the biosimilar development Q&A guidelines by the US Food and Drug Administration, which simplifies pharmacokinetic testing requirements for biosimilars.
A key change in the revision relaxes the criteria for reference drugs used in clinical comparisons. Previously, companies seeking entry into the US market had to conduct pharmacokinetic comparative trials using US-approved reference drugs. Under the new guidelines, comparisons using non-US reference drugs will also be recognized.
Celltrion said the change could reduce overall clinical development costs by up to 25 percent, particularly in areas such as immuno-oncology, where reference drugs are expensive.
The company added that the regulatory easing will allow it to accelerate development and allocate resources more efficiently across its pipeline.
With a fully integrated structure spanning drug development, manufacturing and direct global sales, Celltrion expects to reinvest the cost savings into expanding its biosimilar portfolio, including products targeting smaller or mid-sized markets.
The company currently markets 11 biosimilar products and aims to expand its portfolio to 41 products by 2038.
Celltrion estimates the combined market size for those products could exceed 400 trillion won ($296 billion), more than four times larger than the 85 trillion won market its existing products targeted last year.
“Global regulatory easing presents a major opportunity for us to reduce development costs and accelerate pipeline expansion,” a company official said, citing the firm’s capabilities in early-stage development, large-scale manufacturing and direct sales.
stlee0329@heraldcorp.com
