The biotech market in Japan is one of the largest in the world at over $15 billion. With various government incentives such as tax exemptions and annual funding, the biotech market is steadily growing. Foreign companies have also increased their presence with subsidiaries in Japan, especially with more lenient financial requirements to establish branch offices.
The Pharmaceuticals and Medical Devices Agency (PMDA) has recently proposed a biosimilar approval pathway to expedite drug registration and approval processes. At the PMDA 1st International Symposium on Biologics, a framework was presented where the PMDA will look for comparability with an approved, precursor product. There are various pathways to reach the comparability, from citing nonclinical and clinical studies to referencing a manufacturer’s accumulated experience and data.
The main factors the PMDA focused on for comparability were the presence of highly similar quality attributes before and after manufacturing processes between the two products and no adverse impact on the safety and efficacy of the new product.
The PMDA hopes that with comparability studies, the need to test data during product registration would be reduced. With decreased testing requirements, the PMDA also hopes that drug development will become more effective and economical. However, the PMDA admitted that comparability studies may not be sufficient in ensuring the quality, safety, and efficacy of the subsequent product. Also, the PMDA has suggested that this comparability may only be available for nonconjugated protein products and not for conjugate proteins. Examples of nonconjugated protein products include insulin, somatotropin (hGH), and filgrastim.
Japan is taking strides to address its growing biotechnology market. However, the Symposium also covered many other issues which Japan will have to address in the future. For example, the PMDA suggested close post-marketing surveillance and monitoring to ensure the quality, safety, and efficacy of the newly-approved subsequent product. In addition, the PMDA proposed comparability studies for each intended indication, while different dosage forms or new indications different from the original product would require extensive data.