Regulations

First US Epogen Biosimilar Approved as Pfizer Fixes GMP Issues in Kansas

The FDA upgraded Pfizer’s troubled McPherson, Kansas facility in January paving the way for the approval of Retacrit – a biosimilar version of Amgen’s Epogen (epoetin alfa). The US Food and Drug Administration (FDA) approved Retacrit as the first biosimilar version of Amgen’s anemia drug Epogen yesterday. “The FDA’s decision to approve Retacrit for all indications of the reference product marks a critical and positive step forward in helping create a marketplace for biosimilars in the US, further advancing opportunities…

PBL 3,000L Plant Could Alleviate Erwinaze Shortage

Porton Biopharma Limited (PBL) has opened a facility in Wiltshire, UK to make cancer drug Erwinaze (asparaginase Erwinia chrysanthemi). PBL is a biomanufacturer owned by the UK Government. Construction of the 2,100 m2 facility began in May 2016, through a multi-million pound investment from the UK’s Department of Health Capital funding. The plant has opened its doors and full production is set to commence over the next 12 months once the process of qualifying and validating the equipment is complete.…

Samsung BioLogics: Rise of Biosimilars Behind Bioepis Accounting Change

Samsung BioLogics says it did not violate accounting rules. Change in its financial reporting related to plans by Biogen to up its stake in biosimilar JV, Samsung Bioepis. South Korea’s Financial Supervisory Service (FSS) released a preliminary statement last week accusing contract development and manufacturing organization (CDMO) Samsung BioLogics of accounting fraud. The special yearlong audit investigated a turnaround in Samsung BioLogics’ financials, when after years of losses it reported profits of KRW 1.9 trillion (US$1.8 billion) in 2015 ahead…

Teva: Migraine Mab Delay After ‘Negative Surprise’ of Celltrion Warning

Manufacturing issues are likely to delay the approval of fremanezumab but Teva remains confident its migraine drug will launch this year. Teva Pharmaceutical Industries’ monoclonal antibody (mAb) candidate fremanezumab is under regulatory review as a preventive treatment for chronic migraine. The US Food and Drug Administration (FDA) has assigned fremanezumab a Prescription Drug User Fee Act (PDUFA) action date mid-June, but the firm announced yesterday it expects a delay on the decision due to manufacturing issues. “There’s not much doubt about…

Sandoz Receives CRL for Rituxan Biosimilar

Novartis’ Sandoz remains committed to further discussions with the US FDA after receiving a complete response letter (CRL) for its rituximab biosimilar candidate. The Biologics Licensing Application (BLA) for Sandoz’ proposed biosimilar of Roche’s autoimmune disease drug Rituxan (rituximab) suffered a setback yesterday when the US Food and Drug Administration issued a CRL. A Sandoz spokesperson told BioProcess Insider that the firm is “still evaluating the content” of the letter and specific details are not being divulged for now. “The…

Jazz Pays Spark $110m for Luxturna Priority Review Voucher

Spark Therapeutics has sold its Rare Pediatric Disease Priority Review Voucher (PRV) to Jazz Pharmaceuticals for US$110 Million (€92 million). Spark Therapeutics received the PRV from the US Food and Drug Administration (FDA) when its gene therapy for inherited retinal disease, Luxturna (voretigene neparvovec), was approved. But the firm disclosed in an SEC filing it is selling the voucher to Ireland-headquartered biopharma firm Jazz to help support its future R&D. “We will invest the proceeds from the sale back into the…

AbbVie Braces for 20% Erosion as EU Humira Biosimilars Assemble

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,…

Another Biosimilar CRL for Pfizer, but Manufacturing not the Cause

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…