Samsung Bioepis, a subsidiary of Samsung Epis Holdings, has secured the third "exclusive supply rights" for a biosimilar (a copy of a biologic drug) in Brazil, the largest pharmaceutical market in Latin America and the Caribbean.
Analysts assess that this move lays the foundation for an emerging market strategy by accumulating "evidence" regarding manufacturing and supply safety, in addition to securing stable revenue.
Samsung Bioepis said Tuesday that it signed a local partnership agreement with Brazil's Ministry of Health to supply 'SB12' (active ingredient: eculizumab), a biosimilar of the rare disease therapy 'Soliris'.
This contract was concluded through the Brazilian government's PDP (Productive Development Partnership) system. The PDP is a policy in which the Brazilian government facilitates a tripartite partnership between global pharmaceutical companies, local pharmaceutical companies, and state-owned research institutional investors, transferring product manufacturing technology for a certain period while legally guaranteeing exclusive (priority) purchase of the item for 10 years within the Unified Health System (SUS), which covers 70% of the total population.
Samsung Bioepis will form a partnership with local pharmaceutical company 'BioNovis' and state-owned research institutional investor 'Biafarma' to advance supply procedures for 'SB12'. Previously, the company signed PDP contracts in 2019 for 'SB4 (Enbrel biosimilar, active ingredient: etanercept)', a therapy for autoimmune diseases, and in 2020 for 'SB3 (Herceptin biosimilar, active ingredient: trastuzumab)', an anticancer drug for breast cancer and other conditions, supplying more than 6 million units to date.
Brazil is a market attracting attention from global pharmaceutical companies. According to Statista, a global market research institutional investor, Brazil's pharmaceutical market growth rate in 2024 was 12%, recording the steepest growth among the top 10 global pharmaceutical markets, including Spain (10%), the United States (9.7%), and Italy (9%).
Another market research institutional investor, Fitch Solutions, forecasts that the size of Brazil's pharmaceutical market will expand from $25.1 billion (approximately 37 trillion won) in 2024 to $33.2 billion (approximately 46 trillion won) by 2028.
The size of Brazil's eculizumab market was approximately 250 billion won ($170 million) last year, and this contract is expected to serve as an opportunity for Samsung Bioepis to broaden its business base in the local public healthcare market.
Samsung Bioepis said, "Unlike general competitive markets where fierce price-reduction bidding must be conducted every one to two years, PDP contracts guarantee exclusive or priority supply status in Brazil's government public insurance (SUS) market for the next 10 years," adding that "the government-led PDP system is a key element in tackling the growing Brazilian market."
Industry observers also assess that consecutive PDP contracts signed in Brazil will serve as a significant advantage in future bids in other countries. A biopharmaceutical industry official stated, "Samsung Bioepis's 'technology transfer and revenue guarantee' win-win cooperation business model is highly attractive to countries pursuing both stable pharmaceutical procurement and securing domestic production capabilities."
He added that "it can be evaluated as a successful business model not only for expanding influence in the Brazilian market but also in global emerging markets such as Southeast Asia and the Middle East, which have a high proportion of public healthcare and are promoting policies for localizing biologic drugs."
in THEBIO
