CMO Moves: Regulatory catalysts for drug manufacturing-March

CMO Moves: Regulatory catalysts for drug manufacturing-March

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  • June 1, 2022
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As regulatory decisions come to influence the future of a drug on the market, companies have already launched efforts to produce or manufacture these therapies. Every month at Pharmaceutical Technologylet’s take a look at the drugs that are now likely to have an impact on manufacturing volumes after these verdicts.

This analysis is based on a list of contract manufacturing organizations (CMOs) that have been affected by regulatory decisions since the end of March. Pharmaceutical companies that develop these drugs regularly outsource the production of active pharmaceutical ingredients (APIs) and the dose or packaging of the drug to CMOs. An examination, based on the GlobalData Pharmaceutical Intelligence Center’s offer database and PharmSource reports from late March through early April, reveals the impact of regulatory decisions on the manufacturing plans of various therapies. This list includes drugs that received approvals from agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and reimbursement authorities such as the National Institute of Excellence. in Health and Care (NICE) UK.

A compilation of drugs with important regulatory decisions and CMO contracts

Drugs with decisions from the FDA, EMA or NICE since March, the CMOs were hired to manufacture them

As of late March, a number of regulatory verdicts involving organic products have come to fruition. Lonza hit hard, as several organic products he has contracted to manufacture received positive decisions. This included AstraZeneca Evusheld’s long-acting Covid-19 preventive antibody (AZD7442), which received a marketing authorization from the EMA in late March. At the same time, the European regulator also validated the application of Bristol Myers Squibb type II variation for its combination of Opdivo’s leading immunotherapy (nivolumab) with chemotherapy in the neoadjuvant environment for cell lung cancer. Non-small cells in the initial phase, where it is already approved by the FDA. . Once an application has been validated, the EMA’s centralized review procedure begins. This came just days after NICE recommended Opdivo in combination with the anti-CTLA-4 antibody Yervoy (ipilimumab) as a therapy for untreated advanced renal cell carcinoma. The manufacture of these checkpoint inhibitors has been outsourced to Lonza and Samsung Biologics.

In other EMA-related news, the regulator last month approved immunocore Kimmtrak (tebentafusp) new T-cell receptor (TCR) therapy. The bispecific protein consists of a TCR fused with an anti-CD3 immune effector function, and AGC Biologics has been contracted to manufacture its API, while Baxter Biopharma Solutions is responsible for manufacturing and parenteral packaging.

Developing drugs for rare diseases is a challenge, but the case of the bluebird bio Zyntelgo has only shown that what comes next is just as important. Although the EMA approved this therapy for beta thalassemia in the summer of 2019, Zyntelgo’s price of 1.6 million euros ($ 1.8 million) discouraged many and, finally, the last year the company decided to end its operations. In late March, Bluebird withdrew its marketing authorization for the therapy, the production of which has been outsourced to Lonza, BioReliance and Patheon, by ThermoFisher Scientific, of the European Commission.

As Covid-19’s targeting continues to evolve, GlaxoSmithKline’s Xevudy (sotrovimab) monoclonal antibody, whose API production has been outsourced to Samsung Biologics and Wuxi Biologics, has taken a turn for the worse. . The FDA suspended the use of Xevudy in early April, after initially limiting it because it was ineffective against the subvariant Omicron BA.2.

This data is based on the GlobalData Pharmaceutical Intelligence Center offer database and PharmSource reports.

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