AbbVie expects impact from Humira (adalimumab) biosimilars in Europe beginning the fourth quarter but remains confident there will be no direct US competition until 2022. AbbVie is preparing for Humira biosimilar entrants beginning in the fourth quarter 2018, the firm said during a first quarter conference call. A settled lawsuit with Samsung Bioepis earlier in the quarter laid the way for the Korean firm’s adalimumab biosimilar Imraldi to be launched as soon as October 16 by commercialization partner Biogen. Meanwhile,…

Pfizer has received a US FDA complete response letter (CRL) for its proposed version of Roche’s breast cancer monoclonal antibody Herceptin (trastuzumab). Pfizer announced its biologics license application (BLA) for PF-05280014 has been turned down by the US Food and Drug Administration (FDA), with the agency highlighting the need for additional technical information in the CRL. The requested information does not relate to safety or clinical data, Pfizer said in a release. The news comes less than a year after…