Crossing the approval hurdle for a new drug is a major milestone for pharmaceutical companies. However, efficiently manufacturing drugs represents another hurdle to surmount before the full revenue potential can be successfully realized.
every month, pharmaceutical technology Review recent decisions by regulatory and reimbursement agencies and identify key manufacturers that may be affected by them. Contract Manufacturing Organizations (CMOs) are critical to ensuring adequate and timely production of pharmaceuticals and are involved every step of the way.
For this version, pharmaceutical technology Consider regulatory decisions from late September to early November. This data breakdown is based on the GlobalData Pharma Intelligence Center’s Deals database and PharmSource reports. GlobalData is the parent company of pharmaceutical technology. These contracts involve the manufacture of biological and small molecule active pharmaceutical ingredients (APIs), injectable formulation manufacturing and packaging, and other manufacturing-related tasks.
Regulatory decisions are made
In late September, the European Commission approved the rare disease therapy Ultomiris (ravulizumab), developed by AstraZeneca subsidiary Alexion, to treat generalized myasthenia gravis. The EMA provided a positive opinion on the marketing authorization back in July. Monoclonal antibodies (mAbs) have been approved for the treatment of paroxysmal nocturnal hemoglobinuria in children and adolescents. Fujifilm Diosynth Biotechnologies and Patheon, provided by ThermoFisher Scientific, The task is to produce a biological API for this therapy.
On Sept. 16, another rare disease therapy, bluebird bio’s Skysona (elivaldogene autotemcel) won FDA approval for the treatment of early active cerebral adrenoleukodystrophy (CALD) in boys ages 4 to 17. Biological API manufacturing has been outsourced to BioReliance Corp , Lonza and Minaris Regenerative Medicine, while Minaris is also assigned to Skysona for injectable manufacturing and packaging.
On the same day, the EMA approved AstraZeneca’s long-acting COVID-19 antibody combination Evusheld (tixagevimab and cilgavimab) for the treatment of adults and adolescents at increased risk of developing severe COVID-19 who do not require supplemental oxygen. However, five major COVID-19 treatments, including Evusheld, were not recommended in draft guidelines by the UK’s National Institute for Health and Care Excellence (NICE) a few weeks ago. Biological APIs are produced by Lonza Group and Samsung Biologics, which is also responsible for the production and packaging of injectables.
Swissmedic approved Pfizer/BioNTech’s bivalent Comirnaty booster following similar decisions by US and European regulators. Several companies have been commissioned for the parenteral production and packaging of the vaccine, including Allegropharma GmbH; Baxter Biopharmaceutical Solutions; Delphi; Lek dd, a Sandoz company; Lonza; Mibe GmbH Arzneimittel; Novartis; Shenxian; and Siegfried Holding Company.
Also in September, the US FDA expanded the label for Sanofi/Regeneron Pharmaceuticals’ Dupixent (dupilumab) to include prurigo nodularis. Catalent has been engaged in the parenteral manufacturing and packaging of anti-IL-4/IL-13 antibodies.
NICE in the UK provides guidance on the cost-effectiveness of new treatments; the UK’s National Health Service considers this guidance when making reimbursement and coverage decisions. In the case of Bristol-Myers Squibb’s Zeposia (ozanimod), authorities support its use in moderate-to-severe ulcerative colitis. For Zeposia, Carbogen and Patheon are producing small molecule APIs, while the latter is also responsible for solid dose manufacturing and packaging.
The agency did not support the use of Takeda Pharmaceutical Co.’s Entyvio (vedolizumab) in adults with chronic refractory pouchitis after surgery for ulcerative colitis, citing the company’s failure to present evidence for the same.AbbVie and Lonza are producing the biological API, while Delpharm is in charge of the parent manufacturing.
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