EMA Announces Withdrawal of Marketing Authorization for medac's Anticancer Generic Pemetrexed medac
Withdrawal of Pemetrexed medac by the European Medicines Agency
The European Medicines Agency (EMA) has officially updated its database to reflect the withdrawal of the marketing authorization for 'Pemetrexed medac,' a generic treatment for non-small cell lung cancer (NSCLC) held by the German oncology specialist medac GmbH, effective August 28, 2026. This regulatory change comes approximately 11 years after the final approval from the European Commission (EC) on November 26, 2015. The withdrawal was confirmed following medac's voluntary surrender of the marketing authorization based on commercial judgment, rather than due to any safety or efficacy issues with the drug itself.
Mechanism of Action of Folate Antimetabolites and Key Clinical Indications
Pemetrexed is a folate antimetabolite that inhibits the folate metabolic pathway essential for cell proliferation. It functions by simultaneously inhibiting Thymidylate Synthase (TS), Dihydrofolate Reductase (DHFR), and Glycinamide Ribonucleotide Formyltransferase (GARFT) within tumor cells, thereby suppressing DNA and RNA synthesis. Based on this mechanism, it has been widely prescribed for first-line treatment (in combination with cisplatin) of unresectable advanced Malignant Pleural Mesothelioma, as well as first-line chemotherapy, maintenance therapy, and second-line monotherapy for non-squamous NSCLC.
Market Structure Following Generic Oversupply and Original Patent Expiration
Alimta, the original drug by Eli Lilly and Company, was a representative blockbuster that achieved global annual peak sales of $2.7 billion. As substance patents and vitamin combination patents in Europe expired sequentially, numerous multinational generic pharmaceutical companies, including Sandoz, Teva, and Accord Healthcare, entered the market, leading to severe price erosion of over 80%. While medac entered the market with a powder for concentrate injection formulation, the direct background for this authorization withdrawal is analyzed as the difficulty in maintaining profitability in the European market due to the proliferation of competing generic formulations and falling drug prices.
Market Restructuring Toward Immunotherapy Combination Standard of Care and Supply Chain Impact
Currently, the global NSCLC market has firmly established the KEYNOTE-189 regimen—combining Merck & Co.'s immune checkpoint inhibitor 'Keytruda (pembrolizumab)' with platinum-based chemotherapy—as the first-line Standard of Care. While the clinical demand for the Pemetrexed component itself remains robust as a chemotherapy backbone, there is a surging preference in clinical settings for Ready-to-Use (RTU) liquid formulations due to higher ease of preparation. Consequently, the distribution of the existing lyophilized powder formulation in the European market is naturally being absorbed by replacement generics and suppliers of newer formulations, suggesting there will be no disruption in clinical treatment or risks to patient safety.
This marketing authorization withdrawal serves as a representative case of the harsh price erosion and margin compression faced by mature generic product groups in the global non-small cell lung cancer (NSCLC) market, which exceeds $30 billion annually. Following the peak sales of $2.7 billion for Eli Lilly's (LLY) Alimta, patent expiration led to the entry of multiple generic formulations from companies such as Sandoz, Teva, and Accord, resulting in a price drop of over 80% and medac's commercial withdrawal. While clinical demand for the pemetrexed molecule remains robust given that three-drug combination therapy with immunotherapies such as Keytruda (MRK) has been established as the first-line standard of care (based on Phase 3 KEYNOTE-189), in-hospital prescribing is shifting toward liquid formulations due to their superior dispensing convenience. In the short term, medac's existing market share of Pemetrexed in Europe is expected to rapidly shift to top replacement generic suppliers such as Sandoz and Pfizer. In the mid-to-long term, this implies that for generic and biosimilar developers, developing differentiated drug delivery formulations (RTU/high concentration) and optimizing stable supply chains is an essential condition for survival, rather than merely maintaining simple generic authorizations.
Source: EMA (ema)
https://www.ema.europa.eu/en/medicines/human/EPAR/pemetrexed-medac