Samsung Epis, a subsidiary of Samsung Epis Holdings, has secured the "exclusive supply rights" to its third biosimilar (biologic copy drug) in Brazil, the largest pharmaceutical market in Latin America. Analysts note that this move not only ensures stable revenue but also accumulates "evidence" regarding the safety of manufacturing and supply, laying a foundation for expanding into emerging countries.
Samsung Epis 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 treatment '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 firms, and state-owned research institutions.
Under this framework, production technology for specific products is transferred over a set period, and exclusive (priority) purchasing of those items through the Unified Health System (SUS), which covers 70% of the total population, is legally guaranteed for 10 years.
Samsung Epis signed partnerships with local pharmaceutical company 'BioNovis' and state-owned research institution 'Biafarma' to advance supply procedures for SB12 and other matters.
Previously, Samsung Epis had also concluded PDP contracts in 2019 for the autoimmune disease treatment 'SB4' (a biosimilar of 'Enbrel', active ingredient: etanercept) and in 2020 for the anticancer agent 'SB3' (a biosimilar of 'Herceptin', active ingredient: trastuzumab), 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 firm, 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 firm, Pitch 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 scale 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 Epis to broaden its business base in the local public healthcare sector.
Samsung Epis emphasized, "Unlike general competitive markets where fierce price-reduction bidding must be conducted every one to two years, PDP contracts guarantee an exclusive or priority supply position 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 the consecutive PDP contracts concluded in Brazil will serve as a significant advantage when bidding in other countries in the future.
A biopharmaceutical industry official stated, "Samsung Epis's 'technology transfer + revenue guarantee' win-win cooperation business model is highly attractive to countries pursuing both stable pharmaceutical procurement and securing domestic production capabilities."
The official added, "This 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, where public healthcare accounts for a large share and policies promoting the localization of biopharmaceuticals are being pursued."
in THEBIO
