Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – May 2024

USA

EPA, FDA, and USDA Release Joint Biotechnology Regulatory Plan

In alignment with President Biden’s Executive Order 14081, the EPA, FDA, and USDA have issued a coordinated plan to modernize and clarify regulatory oversight for biotechnology products. The initiative aims to streamline processes and support innovation while ensuring safety within the U.S. bioeconomy.

FDA Approves First Interchangeable Biosimilar for Two Rare Diseases

The FDA has approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab). It is approved for:

• Reducing hemolysis in patients with paroxysmal nocturnal hemoglobinuria (PNH). 
• Inhibiting complement-mediated thrombotic microangiopathy in patients with atypical hemolytic uremic syndrome (aHUS). 

EUROPE

Conditional Approval Recommended for New Haemophilia B Gene Therapy

The EMA has recommended conditional marketing authorization for Durveqtix (fidanacogene elaparvovec) to treat adults with severe or moderately severe haemophilia B who lack factor IX inhibitors and have no detectable antibodies to AAVRh74var.

First EU Vaccine Against Chikungunya Receives Positive Recommendation

The EMA has recommended approval of Ixchiq, the first EU vaccine for adults aged 18 and older to protect against Chikungunya, a mosquito-borne viral illness. It is administered as a single dose.

EMA Recommends Suspension of 17-OHPC Medicines

The EMA’s PRAC committee has recommended suspending the authorization of medicines containing 17-hydroxyprogesterone caproate (17-OHPC). Concerns include a potential—but unconfirmed—risk of cancer associated with in‑utero exposure, and new evidence suggesting the product does not prevent premature birth.

AUSTRALIA

GMP Forum 2024 Scheduled for November

The TGA will host its annual two-day GMP Forum in November. The event will provide regulatory insights, interactive sessions, and expanded networking opportunities for industry stakeholders.

CANADA

Upcoming Announcement on Seniors’ Health Care

Federal and provincial ministers will make a joint announcement addressing new initiatives related to seniors’ healthcare in Canada.

Statement on Canada’s Overdose Crisis

The Minister of Mental Health and Addictions emphasized the severity of the ongoing overdose crisis. Driven by an increasingly toxic illegal drug supply, the crisis demands a comprehensive response spanning prevention, harm reduction, treatment, and enforcement.

INDIA

Withdrawal of an Indication for Olaparib Tablets

Regulators have withdrawn the indication for Olaparib 100 mg/150 mg tablets used to treat gBRCA‑mutated advanced ovarian cancer in patients previously treated with three or more lines of chemotherapy. Other approved indications for ovarian and breast cancer remain unchanged.

MALAYSIA

Updated Application Forms for Biologics

NPRA has released updated application forms for biologics to support regulatory submissions.

Revised Timelines for Variation Applications

NPRA plans revisions to timelines for variations to registered products across pharmaceuticals, biologics, and natural/health supplement categories to enhance clarity and efficiency.

SINGAPORE

Update on Reclassified Medicines

Singapore uses three access levels for therapeutic products:

• Prescription Only Medicines (POM) – require diagnosis and supervision by a doctor.
• Pharmacy Only Medicines (P) – available from pharmacists for self-limiting conditions.
• General Sale List (GSL) – available for self-care without medical oversight.