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Changing Regulations and ‘Sea Turtles’ Drive China Biotech Boom

Backed by US$260 million, Brii BioSciences is the latest firm benefiting from regulatory and economic changes in China. Insider spoke with expert David Deere to discover why the Chinese market is finally opening up. Funded by a group of six venture capitalists firms, Brii Bio is the latest, and one of the largest, examples of the surge of investment and innovation in Chinese biotech. “Brii Bio aims to accelerate the development and delivery of breakthrough medicines in China through partnerships,…

Biosimilar Bulletin: EU Success for Sandoz, Amgen Stumbles Stateside

by Dan Stanton

Sandoz says it will use a third-party manufacturer as its proposed Humira biosimilar receives recommendation in Europe. Meanwhile, the US FDA has rejected Amgen’s proposed Herceptin biosimilar. Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Halimatoz, Hefiya and Hyrimoz – all versions of AbbVie’s best-selling Mab Humira (adalimumab) submitted by Novartis subsidiary Sandoz. “To ensure the majority of eligible patients gain access to our biosimilar medicines as soon as possible,…

Teva Migraine MAb Approval Reliant on Celltrion Plant Fix

by Dan Stanton

FDA approval of Teva’s fremanezumab depends on a speedy resolution of a plant run by CMO Celltrion but this is looking increasingly likely, an analyst says. The US Food and Drug Administration (FDA) had set the Prescription Drug User Fee Act (PDUFA) action date for fremanezumab, a humanized monoclonal antibody targeting calcitonin gene–related peptide (CGRP) for mid-June. But Teva Pharmaceutical Industries envisioned a delay after its contract manufacturer Celltrion received an FDA warning letter in January. Celltrion’s site in Incheon,…

Topical Herpes Virus-Based Gene Therapy Granted FDA Fast Track

by Dan Stanton

Krystal Biotech’s lead candidate has received FDA fast track designation for the treatment of dystrophic epidermolysis bullosa (DEB). The firm is building a GMP facility in Pennsylvania to support future scale-up. The US Food and Drug Administration (FDA) granted fast track designation to KB103, a topically-applied gene therapy engineered to deliver a human collagen protein to patients suffering from DEB. The designation will help expedite the development and review process of the allogeneic gene therapy, and is a boost for…

Coherus Resubmits Neulasta Biosimilar, Aims for November Approval

by Dan Stanton

With successful preapproval inspections at its manufacturing sites, Coherus BioSciences is confident its CHS-1701 pegfilgrastim biosimilar will be approved by the end of the year. In 2017, California-based Coherus received a US Food and Drug Administration (FDA) complete response letter (CRL) for its version of Amgen’s Neulasta (pegfilgrastim), CHS-1701. The CRL requested a reanalysis of a subset of subject samples with a revised immunogenicity assay, along with additional manufacturing related process information. Earlier this month, Coherus announced it resubmitted its…

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

by Dan Stanton

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

by BPI Staff

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

by Dan Stanton

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

by Dan Stanton

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

by Dan Stanton

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…