Regulations Archives - Page 26 of 27 - BioProcess InternationalBioProcess International

US FDA Calls Biologic Makers to ‘INTERACT’ With New Program

The Agency has launched the INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs) program to help sponsors plan development projects more effectively. The program is being introduced by the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) to allow potential sponsors to engage with Agency staff and obtain advice on a specific topics or issues critical to early product development. The discussions aim to advance product development by answering sponsors’ questions, removing roadblocks,…

Plant on the Road to Remediation as Celltrion Resubmits Biosimilars

by Dan Stanton

Celltrion has completed the resubmission of versions of Herceptin and Rituxan to the US FDA after receiving complete response letters for the two biosimilars in April. Earlier this year, the US Food and Drug Administration (FDA) issued complete response letters (CRLs) to South Korean drugmaker Celltrion for its rituximab and trastuzumab biosimilars. The letters cited a warning letter sent to the firm in January highlighting “multiple poor aseptic practices” at its production site in Songdo, Incheon. The firm resubmitted CT-P10, a proposed biosimilar…

Lack of Interchangeable Biosimilars Keeps J&J in the Infliximab Game

by Dan Stanton

While US infliximab biosimilars lack interchangeability approval, Remicade (infliximab) can continue to compete in an open market place, says Janssen. Pfizer launched its a biosimilar to Remicade (infliximab), Inflectra, in 2016. The following year, Samsung Bioepis/Merck & Co.’s Renflexis became the second direct threat to Johnson & Johnson subsidiary Janssen’s blockbuster monoclonal antibody. But both products, while deemed by the US Food and Drug Administration (FDA) to be biosimilar to Remicade, have not been approved to be interchangeable with the…

Benitec Scale-Up Success with Insect-Based Tech Ahead of IND Filing

by Dan Stanton

Benitec Biopharma says it has successfully scaled-up its investigational oculopharyngeal muscular dystrophy (OPMD) gene therapy using a baculovirus-based expression system. Benitec Biopharma’s lead candidate BB-301 is a gene therapy for the treatment of oculopharyngeal muscular dystrophy (OPMD), a disease caused by a mutation of the poly(A)-binding protein nuclear 1 (PABPN1) gene. The candidate received orphan drug status from the US Food and Drug Administration (FDA) in January this year, and the firm hopes to bring it into the clinic by…

Changing Regulations and ‘Sea Turtles’ Drive China Biotech Boom

by Dan Stanton

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…