Updated on 16 May 2012
Sharing his thoughts, Dr Wassim Nashabeh, global head, Technical Regulatory Policy and Strategy, Genentech, comments that biosimilars development is a $100 million investment for one molecule. "Only those players will enter this game who have a sound investment stream and seriousness to stay in the market. The US market is open to Asia but do Asian companies have the patience, time and money to withstand the stringent regulatory process? China has strong regional biosimilars players, but can they elevate the compliance mechanism in order to match US standards? If they can, they have the market but Asia is yet to achieve those compliance standards. Korean companies have shown seriousness to reach a larger market."
Celltrion has an alliance with the US-based Hospira for development of biosimilars. Similarly, LG Life Sciences completed its phase III clinical trial of its slow-release recombinant human growth hormone somatropin weekly, and is getting its biologics license application ready for the US FDA.
"First, we have to recognize that the US biosimilars pathway is designed to provide access to high-quality biologics through cost competition. Secondly, a biosimilars manufacturer can use prior experience of the original manufacturer to abbreviate their biosimilars development program. This second component is dependent on the manufacturer demonstrating that their biosimilars is "highly-similar" to the original biologic and requires a science-based approach for generating such data," says Mr Mark McCamish, global head of Biopharmaceutical Development, Sandoz.
He adds that in Asia, patient access is a driving force behind creating follow-on biologics to meet demand in the market place. Various countries meet these needs without requiring the same rigorous demonstration of a high degree of similarity to the originator molecule. "This approach has allowed for non-comparable follow-on biologics to enter the market in these regions and address an unmet medical need. However, to commercialize these molecules in the highly-regulated markets, such as Europe and the US, they will have to meet a high scientific standard of comparability," he says.
Mr McCamish suggest that to accomplish a closer alignment with the US regulators, Asian regulators can develop a "science-based" regulatory pathway like many of the highly regulated markets. This will ensure that patients in these countries will have access to safe and effective biosimilars.