Mundipharma, a German pharmaceutical company, has achieved a significant milestone with the European Commission (EC)’s approval of Pelmeg, its pegylated biosimilar to Amgen’s Neulasta (pegfilgrastim). Designed to reduce the duration of neutropenia and associated infections in adults undergoing chemotherapy, Pelmeg provides a cost-effective alternative to traditional treatment options.

EU Approval of Pelmeg for Neutropenia

The European Commission’s endorsement allows Pelmeg to address chemotherapy-induced neutropenia—a severe reduction in neutrophil levels crucial for infection control. While approved to treat neutropenia in patients receiving cytotoxic chemotherapy, it is not authorized for chronic myeloid leukaemia or myelodysplastic syndromes. Mundipharma’s new solution aligns with the European Medicines Agency’s (EMA) commitment to expanding access to safe and effective biosimilars.

How Pelmeg Works in Combating Neutropenia

Pelmeg operates by stimulating bone marrow to increase neutrophil production, effectively reducing infection risks for chemotherapy patients. Like its counterpart, Neulasta, Pelmeg requires subcutaneous administration. The biosimilar’s approval follows a detailed review by the EMA’s Committee for Medicinal Products for Human Use (CHMP), which examined Pelmeg’s biosimilarity based on analytical, biofunctional, and clinical studies.

Expert Insight: Potential Benefits for Healthcare Costs and Access

Philippe Bastide, Head of Biosimilars at Mundipharma International, emphasized that the approval of Pelmeg is likely to ease healthcare expenses while enhancing treatment access for patients affected by chemotherapy-induced neutropenia. Bastide suggested that Pelmeg’s availability could “significantly improve the lives” of those managing the impacts of chemotherapy.

Expanding the Biosimilars Market

Pelmeg marks the fourth biosimilar Mundipharma has brought to market, signaling the company’s commitment to the growing field of biosimilar therapeutics. This approval also follows Mundipharma’s recent acquisition of Cinfa Biotech, a biosimilar developer previously owned by Spain’s Cinfa Group, strengthening its biosimilar portfolio.

Mundipharma’s Pelmeg represents a critical advancement for both patients and healthcare systems, providing an affordable and effective solution to address chemotherapy-induced neutropenia. As biosimilars like Pelmeg gain momentum, the European healthcare landscape may see significant shifts in cost and accessibility for life-saving treatments.

  Amgen, Cinfa Biotech, Cinfa Group, Europe, European Commission, European Medicines Agency, Mundipharma, Neulasta, Neutropenia, Pegfilgrastim, Pelmeg, Philippe Bastide