Biocon on September 12 said it has signed a license and supply agreement with a subsidiary of China Medical System Holdings (CMS) for three generic formulation products in Greater China.
Biocon, however, has not specified which products are going to be part of this deal.
Under the terms of the agreement, Biocon will be responsible for the development, manufacturing and supply of the products while CMS will be responsible for registration and commercialisation of the products in China.
The initial term of the agreement shall be for 10 years from the date of commercialisation, extendable by two years on a product basis by mutual consent. This collaboration can be extended to a broader portfolio in future.
The total addressable market size for these three products in Mainland China is about $800 million, as per recent IQVIA data.
This development is in line with Biocon’s long term generic formulations strategy and expands our generic formulations business footprint to the Chinese pharmaceuticals market, which is the second largest pharmaceutical market in the world, the company said.
“This collaboration will allow us to take our US approved Generic Formulations to patients in China, allowing us an early entry in the world’s second largest, and rapidly-growing generics market,” said Arun Chandavarkar, CEO and Joint Managing Director, Biocon.
Indian companies are lining up partnerships with local Chinese firms to launch products in that market, as drug regulator there speeds up approvals, especially for drugs approved by USFDA.
Earlier India’s largest drug maker Sun Pharma entered into a similar deal with CMS to commercialise eight products in China.
China’s regulation the National Medical Products Administration (NMPA) has recently introduced the Quality Consistency Evaluation (QCE) system, which aims to ensure that all generic medicines marketed or manufactured in China meet internationally recognized quality standards.
The QCE regulations are part of a wide-ranging package of healthcare system reforms introduced by the Chinese government over the past few years to accelerate generic penetration.