In the first 2023 edition of the CMO Moves monthly series, ÎÛÎÛÂþ®‹ Technology explores recent news stories on regulatory and reimbursement decisions in different countries, and the companies linked to their success and failures.

In order to get a therapy to the market, pharma companies often outsource the drug manufacturing to specialist contract manufacturing organizations (CMOs). Using the manufacturing contract-related data collated from PharmSource reports, and news from the GlobalData Pharma Intelligence Center, ÎÛÎÛÂþ®‹ Technology has collated some of the key regulatory events from late November to late December that will likely impact manufacturing volumes, and stakeholders that will likely be affected.

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EMA and NICE news

The UK’s National Institute for Health and Care Excellence (NICE) conducts health technology assessments (HTAs) based on a cost-effectiveness analysis for the given use of a therapy in a specific setting. In late November, the agency of Kymriah (tisagenlecleucel) for treating follicular lymphoma after two or more therapies, after did not provide an evidence submission. The agency cited the Kyprolis (carfilzomib) with Janssen Oncology’s Darzalex (daratumumab) and dexamethasone to treat relapsed/refractory multiple myeloma, when did not submit the necessary data.

Regulatory announcements by the EMA and reimbursement decisions by UK’s NICE from late November to mid-December, for select therapies and the CMOs contracted to manufacture them.
Source: GlobalData ÎÛÎÛÂþ®‹ Intelligence Center

In the case of the chimeric antigen receptor (CAR)-T therapy Kymriah, Fraunhofer Society for the Promotion of Applied Research eV, Cell Therapies, Group, and are contracted to manufacture the biologic active pharmaceutical ingredient (API).

On November 30, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) to Lupkynis (voclosporin) for the treatment of lupus nephritis. While and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. The Institute for Clinical and Economic Review (ICER) had previously announced a favorable cost-effectiveness assessment for this drug for this condition.

In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children. SA, AG, Uquifa SA, and Yuhan Chemical Inc are manufacturing the small molecule API.

The EMA also expanded the label of Skyrizi (risankizumab) to include its use to treat moderate-to-severe Crohn’s disease. is contracted for the parenteral manufacturing and biological API production for Skyrizi.

On December 5, the ’s Mycapssa (octreotide), the only oral somatostatin analog indicated to treat acromegaly. Earlier this month, Amryt was in the news when signed an agreement to acquire Amryt for $1.48 billion.

FDA expands approval labels

The FDA passed several positive supplementary approval decisions involving younger patients. The agency expanded the use of Trulicity (dulaglutide) injection to patients ages 10 years and older, to improve glycemic control as an adjunct to diet and exercise. Vetter Pharma-Fertigung GmbH & Co KG is conducting the parenteral manufacture and packaging for Trulicity. On November 10, the FDA also expanded the label of to treat with previously untreated high-risk classical Hodgkin lymphoma (cHL) in combination with other standard drugs. has contracted the antibody drug conjugate’s (ADC) manufacturing to several companies. Baxter Biopharma Solutions, Fareva SA, BSP ÎÛÎÛÂþ®‹s SpA, and are manufacturing the parenteral portion of the ADC.

Regulatory decisions by the US FDA from late November to mid-December for select therapies, and the CMOs contracted to manufacture them.
Source: GlobalData ÎÛÎÛÂþ®‹ Intelligence Center

In early December, the FDA approved ’ Rezlidhia (olutasidenib) as a with an IDH1 mutation. Inc has been tasked with the solid dose manufacturing for the drug.

To read the previous editions in this series, click here, and here.