EU-Wide Marketing Authorization Obtained

Slovenian pharmaceutical company Krka, d. d., Novo mesto (KRKG·KRK) received EU-wide marketing authorization for Pomalidomide Krka on July 24, 2024. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on May 30 of the same year, which was subsequently approved by the European Commission. This product is not a new drug requiring additional late-stage clinical trials, but a marketed generic authorized based on quality and bioequivalence.

Drug and Patient Population

The brand name is Pomalidomide Krka, with the generic name pomalidomide, and the reference drug is Bristol Myers Squibb (BMY)'s Imnovid (Pomalyst in the U.S.). Pomalidomide is an immunomodulatory drug (IMiD) that binds to the E3 ubiquitin ligase complex substrate receptor cereblon (CRBN), inducing the degradation of IKZF1 and IKZF3. The authorization covers combination therapy with bortezomib and dexamethasone for patients with multiple myeloma who have previously received lenalidomide, and dexamethasone combination therapy for relapsed/refractory patients who have received at least two prior therapies including lenalidomide and bortezomib. Therefore, it targets the subsequent treatment market where therapeutic options are limited, rather than newly diagnosed patients.

Market Potential and Competitive Landscape

The reference brands Pomalyst and Imnovid recorded global sales of USD 3.441 billion in 2023 and USD 3.545 billion in 2024, demonstrating the commercial foundation of the pomalidomide class. However, Krka will face price and tender competition with other pomalidomide generics such as Accord Healthcare, Teva Pharmaceutical Industries (TEVA), and Viatris (VTRS). In clinical practice, subsequent treatment options are also expanding with anti-CD38 therapies like Darzalex/daratumumab, proteasome inhibitors like Kyprolis/carfilzomib, and BCMA bispecific antibodies such as Elrexfio/elenzomab and Tecvayli/teclistimab. The core value of generics lies in oral treatment accessibility and cost savings, rather than direct efficacy differentiation from innovative drugs.

Regulatory History and Business Implications

The original pomalidomide was approved by the U.S. FDA as Pomalyst on February 8, 2013, and by the EU as Imnovid on August 5, 2013, with approval in Japan by PMDA in March 2015. The EU orphan drug exclusivity period ended on August 2023 after a 10-year protection period, creating conditions for generic entry including Krka. This process did not involve an FDA-style advisory committee (AdComm) vote, and in the EU, the CHMP's positive opinion and the Commission's decision were the key regulatory steps. While authorization does not guarantee sales, it provides a commercial foundation for Krka to expand its oncology portfolio and participate in national reimbursement and hospital tender processes.