Pfizer Voluntarily Withdraws Marketing Authorization for Infliximab Biosimilar 'Inflectra' in Europe
Pfizer's Voluntary Withdrawal of Marketing Authorization and Background
According to the European Medicines Agency (EMA), Pfizer's European subsidiary has voluntarily withdrawn the marketing authorization for 'Inflectra,' an infliximab biosimilar used to treat autoimmune diseases. This decision is not related to safety or efficacy concerns but is a result of Pfizer's adjustment of its business strategy in the European market. Approximately 13 years after its initial approval as the first monoclonal antibody biosimilar in Europe in September 2013, Inflectra will officially exit the European market. This reflects the trend of multinational pharmaceutical companies adjusting their portfolios based on market maturity after patent expiration.
Celltrion's Strategy to Strengthen its Direct Sales System in Europe
Inflectra was originally developed by Celltrion of South Korea, with Pfizer responsible for distribution in Europe and other global markets. As Celltrion transitions its European marketing and distribution network from a partner collaboration model to a direct sales model through its own European subsidiaries, the sales agreement with Pfizer has naturally concluded. Celltrion has established over 30 local subsidiaries across Europe and is consolidating its marketing efforts under its own brand, 'Remsima.' Pfizer's brand withdrawal can be interpreted as part of a broader strategy to streamline partner-distributed products and allow the developer to directly control the market.
Impact on the TNF-alpha Inhibitor Market in Europe
The TNF-alpha inhibitor market, to which infliximab belongs, is a mature biosimilar market in Europe. In 2025, the European market for infliximab and biosimilars is estimated at approximately $1.397 billion USD, and the penetration rate exceeds 90% due to the pro-biosimilar policies of European health authorities aimed at maximizing cost savings. Even with Pfizer's Inflectra leaving the market, Celltrion's Remsima intravenous (IV) and subcutaneous (SC) formulations already account for over 70% of the European market, so there is expected to be no impact on patient access to treatment. In fact, the transition to a single-brand system will further enhance price defense and distribution efficiency in the market.
Changes and Implications in Biosimilar Partnership Structures
This event suggests that the collaboration model between developers and global Big Pharma companies, which was established in the early stages of the biosimilar industry, is coming to an end. Developers are now choosing to enhance their independent commercialization capabilities to increase profitability rather than sharing distribution margins with partners. Pfizer has also made regulatory and business decisions to focus on its own pipeline and high-value new drugs in the face of original drug patent expirations and intensifying biosimilar competition. Investors should pay attention to how domestic and international bio companies will stabilize their overseas direct sales systems and improve their operating profit margins in the future.
Pfizer's withdrawal of the Inflectra marketing authorization marks a pivotal moment in the approximately $1.397 billion European infliximab market, formalizing Celltrion's brand unification and strengthening its direct sales system. In the short term, Pfizer's European infliximab sales will cease, but in the long term, Celltrion, as the developer, can maximize profitability by reducing intermediate distribution costs based on its market share of over 70%. In terms of research and product development, competition in the marketing of second-generation biosimilars, which diversify beyond simple intravenous (IV) formulations to include subcutaneous (SC) and high-concentration liquid formulations, will accelerate. Industry stakeholders should respond to the biosimilar portfolio restructuring of competitors such as Amgen and the defensive strategies of original developers such as Johnson & Johnson (JNJ) for Remicade. This regulatory withdrawal case demonstrates a shift in market structure where Asian biotech companies with development capabilities are breaking away from dependence on the distribution networks of global Big Pharma and demonstrating independent global regulatory approval and commercialization capabilities.
Source: EMA (ema)