Samsung Bioepis set to debut fifth biosimilar in Europe: The Committee forMedicinal Products for Human Use (CHMP) on Sep 15 recommended the EuropeanMedicines Agency (EMA) approve Samsung Bioepis’s Herceptin biosimilar Ontruzant(EMEA/H/C/004323), which should be the world’s first Herceptin biosimilar to launchin Europe in early 2018—nb, the original’s patent expired in 2014. With final approvalprobable in November or December, the firm would be alone with five blockbusterbiologics biosimilars available in Europe—for Humira, Enbrel, Remicade, Herceptin, andLantus, which saw global sales of a respective USD16.5b, USD9.2b, USD8.9b, USD6.9b,and USD6.3b last year. Approval would also give the company another first-moveradvantage there after its Enbrel biosimilar.    Herzuma could get the nod from CHMP in December: Mylan on Aug 16withdrew an application with the EMA for its Herceptin biosimilar EMEA/H/C/004346,while on Sep 15 Celltrion submitted a response letter for Day 120 list of questions (LoQ)with the agency for its version (Herzuma). Barring outstanding issues within 60 daysafterwards, the drug should receive an EMA opinion on Day 180 before receiving CHMPrecommendation on Day 210 in December. If the agency finds outstanding issues withinthe initial 60 days, however, Celltrion will have to submit another response letter with theCHMP’s opinion expected no sooner than 30 days thereafter. We therefore expectOntruzant to launch in Europe at least three months ahead of Herzuma.    Set to become largest bio-CMO player in 4Q: Samsung Biologics plans tocomplete the construction and validation of its third plant in 4Q17 and 4Q18, respectively,with its CMO capacity subsequently projected to hit 360,000 liters by 2020 for a32.7% global share. The company already boasts a CMO order backlog of USD2.8b (out ofUSD3.3 in total orders), with negotiations underway with at least 15 overseaspharmaceutical players regarding 30 CMO contracts. Once completed, the third plantought to pave the way for even more order growth.

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