Regulations Archives - Page 15 of 21 - BioProcess InternationalBioProcess International

Pfizer urges FDA for flexibility in considering interchangeability studies

The US FDA has published long-awaited final guidance on the interchangeability of biologics, calling biosimilar developers to carry out switching studies. At the last count, there were 19 biosimilar products approved by the US Food and Drug Administration (FDA) US though only a handful have been launched. None of these products have been deemed interchangeable, meaning they cannot be substituted for the reference biologic at the pharmacy level without the involvement of a physician. However, this theoretically could change going…

Subcutaneous success a boon for Halozyme, but biosimilars hit royalties

by Dan Stanton

Roche’s subcutaneous Herceptin (trastuzumab) recently became the third product to be approved using Halozyme Therapeutics’s ENHANZE drug delivery tech. However, Halozyme’s royalties have been hit by biosimilar competition. Halozyme Therapeutics reported what it described as a “strong start to 2019” with revenues of $57 million (€51 million) – up 84% year-on-year – attributed to $30 million upfront license fee from a license agreement struck with argenx in February. That deal gives argenx access to Halozyme’s ENHANZE drug delivery technology to…

FDA pledges to support cell and gene therapy manufacturing innovation

by Gareth Macdonald

Manufacturers aiming to follow Yescarta and Kymriah to market can count on FDA support after the agency said it will help cell and gene therapy firms adopt better production methods. A US Food and Drug Administration (FDA) spokesman told Bioprocess Insider the agency’s emerging technology team has been tasked with working with cell and gene therapy firms to “identify innovative approaches for efficient product manufacturing.” The move is part of a wider FDA effort to support modernization of drug manufacturing…

Success for Bioepis as FDA approves a second Enbrel biosimilar

by Dan Stanton

The US Food and Drug Administration (FDA) has approved a second biosimilar of Amgen’s Enbrel (etanercept), Samsung Bioepis’s Eticovo. Korea’s Samsung Bioepis has seen regulatory approval for its etanercept biosimilar in numerous markets, including Korea, Europe, Australia, Canada, Brazil, Switzerland and Israel. Now the firm has had the molecule approved in the US under the brand name Eticovo. This is the second biosimilar of Amgen’s autoimmune disease drug Enbrel to be approved by the FDA. In August 2016, Sandoz received…

Novartis prepped for ‘unprecedented’ Zolgensma demand

by Dan Stanton

With over one million square-feet of manufacturing space, Novartis says it is prepared for the imminent approval of AveXis’ SMA gene therapy Zolgensma. Speaking during its Q1 2019 results, Novartis said it is set for the imminent arrival of gene therapy Zolgensma (onasemnogene abeparvovec), added to the firm’s pipeline through the acquisition of AveXis. The one-time therapy targeting spinal muscular atrophy (SMA) Type 1, will be reviewed by the US Food and Drug Administration in May, despite the recent news…

GSK expects normal HPV vaccine supply to resume in June

by Dan Stanton

Manufacturing constraints have led to supply issues concerning GlaxoSmithKline’s HPV vaccine, Cervarix, which are set to continue until June. In a letter sent to French health professionals last month, GlaxoSmithKline (GSK) reported supply issues regarding its product Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant affecting the first half of this year. According to the letter, published by the French authorities the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week, the shortage…

Shareholders’ nod puts $74bn BMS Celgene merger back on track

by Dan Stanton

Over 75% of Bristol-Myers Squibb shareholders voted in favor of the proposed megamerger with Celgene despite warnings from certain investor groups. In January, Big Pharma firm Bristol-Myers Squibb (BMS) announced its intentions to get bigger through the acquisition of its immune-oncology partner Celgene. The $74 billion (€65 billion), if it goes through, will be the largest ever merger in the biopharma space and create what Bristol-Myers Squibb CEO Giovanni Caforio described as “the number one oncology franchise.” The deal is on track…

bluebird opens gene therapy plant as EMA backs gene therapy

by Dan Stanton

The EMA has recommended approving Zynteglo, bluebird bio’s one-off treatment for beta-thalassaemia. Meanwhile the cell and gene therapy firm has cut the ribbon on a 125,000-square-foot facility in Durham, North Carolina. The EMA’s Committee for Advanced Therapies (CAT) recommended Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) – also know as LentiGlobin – today, paving the way for bluebird bio to bring its gene therapy product to market. The product uses a lentiviral viral vector to add functional copies of a…

Biogen stock plunges $18bn on Alzheimer’s MAb failure

by Dan Stanton

Biogen lost around 30% of its value after discontinuing a Phase III trial of Alzheimer’s disease candidate aducanumab. The CRO involved will also take a hit in revenues. Codeveloped with Eisai, aducanumab had been undergoing Phase III clinical trials in patients with mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia. But the firms took the decision to halt the study this week – along with the EVOLVE Phase 2 safety study and the long-term extension of…

Two Form 483s not indicative of systemic manufacturing issues, Biocon

by Dan Stanton

Biocon has received two US FDA 483s with two and six observations at a drug product plant and an insulin API plant, respectively. The first 483 came following a pre-approval inspection of a new injectable manufacturing line for a biologic drug product at the firm’s site in Bangalore, India conducted between February 7 and 15. The Form has since been published by the US Food and Drug Administration (FDA) and the two observations relate to issues with microbial prevention procedures…