Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – Feb 2025

USA

FDA Approves First Rapid‑Acting Insulin Biosimilar for Diabetes

The FDA has approved Merilog (insulin‑aspart‑szjj), a biosimilar to Novolog (insulin aspart), for improving glycemic control in adults and pediatric patients with diabetes mellitus. Merilog— a rapid‑acting human insulin analog— is the first biosimilar of its kind approved in the U.S. It is designed to help reduce mealtime spikes in blood glucose and will be available in both a 3 mL single‑patient prefilled pen and a 10 mL multidose vial.

FDA Approves First Treatment for Cerebrotendinous Xanthomatosis (CTX)

The FDA approved Ctexli (chenodiol) as the first treatment for cerebrotendinous xanthomatosis, an extremely rare lipid storage disorder. CTX is a progressive, multisystem condition that previously had no approved therapies. The approval represents a significant advancement for patients living with this rare metabolic disease.

EUROPE

Expanded Use of Cystic Fibrosis Medicines for Rare Mutations

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indications for Kaftrio (ivacaftor/tezacaftor/elexacaftor) and Kalydeco (ivacaftor). The combination therapy is now recommended for patients aged two and older who have at least one non–class I mutation in the CFTR gene.

First Topical Gene Therapy for Dystrophic Epidermolysis Bullosa

The EMA has recommended authorisation of Vyjuvek (beremagene geperpavec), the first topical gene therapy for treating wounds in patients of any age with dystrophic epidermolysis bullosa (DEB). DEB is an ultra‑rare genetic blistering disease caused by COL7A1 gene mutations and is associated with severe skin fragility, chronic wounds, scarring, and life‑altering complications.

AUSTRALIA

Updated Acceptable Intakes for Nitrosamine and Nitroso‑Structure Impurities

The TGA has released updated guidance on acceptable intake (AI) limits for nitrosamine and nitroso‑structure impurities, aligned with recent EMA updates. The revision includes clarifications for sponsors and manufacturers, minor editorial changes, higher AI limits for certain impurities, and additions of newly established international AI values.

RDC 954/2024 – Key Regulatory Changes for Drug Registration

Anvisa will host an in‑person event titled “RDC 954/2024 – Understanding Key Points and Impacts on Drug Registration,” aimed at providing clarification and deeper insights into the regulatory updates introduced under the resolution.

CANADA

Government Accelerates Actions Against Fentanyl Precursor Chemicals

Health Canada is strengthening efforts to combat the illegal fentanyl supply chain by enhancing detection, disruption, and enforcement measures. These actions support national security, public safety, and cross‑border collaboration to address the growing threat of illegal drug production and trafficking.

JAPAN

PMDA‑ATC Pediatric Review Seminar 2025

The Pharmaceuticals and Medical Devices Agency (PMDA) announced the “PMDA‑ATC Pediatric Review Seminar 2025,” to be held in person at the PMDA Office in Tokyo from June 9–12, 2025. The seminar is open to new drug application reviewers from overseas regulatory agencies.

SINGAPORE

HSA Seizes Nearly One Million Illegal Health Products and Removes Thousands of Listings

The Health Sciences Authority (HSA) intensified its enforcement efforts throughout 2024, resulting in the seizure of 970,707 units of illegal health products and the removal of 7,351 online listings from e‑commerce and social media platforms. These coordinated efforts disrupted illegal supply chains and reduced public exposure to unsafe products.

UK

Approval of mRESVIA RSV Vaccine for Adults 60+

The MHRA has approved the mRNA RSV vaccine mRESVIA for individuals aged 60 and older to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV). While RSV often causes mild, cold‑like symptoms, older adults face a heightened risk of severe illness, hospitalization, and death.

Mepolizumab Approved for Purring Nodular is and Atopic Dermatitis

The MHRA has approved mepolizumab (Nemluvio) for treating moderate‑to‑severe purring nodular is in adults and moderate‑to‑severe atopic dermatitis in patients aged 12 and older. Clinical trials support its safety and efficacy for purring nodular is in adults, though its use in younger patients for that indication has not been established.