Press releases | Mundipharma

Mundipharma wins 1st ever PLG deal of the year award for acquisition of Cinfa Biotech

Win recognises the significance of the deal in enabling Mundipharma to further enhance Mundipharma’s biosimilar platform offering Cambridge. 26th February 2019 – The Mundipharma network of independent associated companies is delighted to anno...continue reading

Mundipharma launches Pelmeg®▼ (pegfilgrastim) biosimilar in Europe

Germany, the Netherlands and Ireland are the first markets to launch Pelmeg®. Pelmeg, a pegfilgrastim biosimilar, is indicated for the reduction of the duration of neutropenia and incidence of febrile neutropenia in adults treated with chemotherapy....continue reading

European Commission approves Pelmeg▼® (pegfilgrastim) as a biosimilar treatment to reduce the duration of neutropenia and incidence of febrile neutropenia in adults treated with chemotherapy

Pelmeg is a pegfilgrastim biosimilar that is delivered subcutaneously to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic ...continue reading

Cinfa Biotech receives positive CHMP opinion for Pelmeg® (pegfilgrastim), a proposed biosimilar to Neulasta®

Munich, Germany, 21 September 2018 – The biosimilar company Cinfa Biotech today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing auth...continue reading

Cinfa Biotech begins US partnering and prepares US development for B12019, a proposed biosimilar to Neulasta® (pegfilgrastim)

Pamplona, Spain, 14 December 2017 – Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today announced the start of US partnering and the preparation of US development for its drug candidate B12019, a biosimilar of Neulasta® (INN pegfil...continue reading

Cinfa Biotech presents additional clinical data for pegfilgrastim biosimilar candidate B12019 at the 59th ASH Annual Meeting

Cinfa Biotech starts US partnering discussions Pamplona, Spain, 2 November 2017 – Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today announced that it will present additional data from the clinical development program of its ...continue reading

European Medicines Agency accepts Marketing Authorisation Application for Cinfa Biotech’s pegfilgrastim biosimilar B12019 for review

Pamplona, Spain, 04 October 2017 Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today reported acceptance of the Marketing Authorisation Application (MAA) by the European Medicines Agency (EMA) for its lead development candidate B12019, ...continue reading

Cinfa Biotech reports clinical development data for pegfilgrastim biosimilar candidate B12019 at the ESMO Congress 2017

New facts disclosed on trial design and results Pamplona, Spain, 05 September 2017 Cinfa Biotech S.L., the biosimilars company of Cinfa Group, reports further data of the clinical development program for its lead development candidate B12019, ...continue reading

Cinfa Biotech announces positive top-line data from second clinical study with pegfilgrastim biosimilar candidate B12019

MAA submission in the EU anticipated in second half of 2017 Pamplona, Spain, 17 May 2017 Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today announced positive top-line data from the second clinical trial with its lead developme...continue reading