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

USA

EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology

In response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) have developed a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology.

FDA Approves First Interchangeable Biosimilar for Two Rare Diseases

Today, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are also currently approved for Soliris:

The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; and the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

EUROPE

New gene therapy treatment for haemophilia B

EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Durveqtix (fidanacogene elaparvovec) to treat severe and moderately severe haemophilia B in adults who do not have factor IX inhibitors (auto-antibodies produced by the immune system against factor IX replacement medicines) and who have no detectable antibodies to variant adeno-associated virus serotype Rh74 (AAVRh74var).

First vaccine to protect adults from Chikungunya

EMA has recommended granting a marketing authorisation in the European Union (EU) for Ixchiq, the first vaccine in the EU to protect adults 18 years and older against Chikungunya. It is given as a single dose.

Chikungunya (also called CHIK fever) is a viral disease caused by Chikungunya virus (CHIKV), a virus transmitted to humans by infected mosquitoes (primarily Aedes aegypti and Aedes albopictus).

Hydroxyprogesterone caproate medicines to be suspended from the EU market

EMA’s safety committee, PRAC, has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union (EU). A review by the PRAC concluded that there is a possible but unconfirmed risk of cancer in people exposed to 17-OHPC in the womb. In addition, the review considered new studies which showed that 17-OHPC is not effective in preventing premature birth; there are also limited data on its effectiveness in other authorised uses.

AUSTRALIA

Save the date – GMP Forum 2024

The TGA’s hugely popular GMP Forum returns in November for a two-day event providing exclusive insights and education in Good Manufacturing Practice (GMP) direct from the regulator. Our new two-day format will give attendees more opportunities to network, participate in interactive sessions and tailor the program to their needs.

CANADA

Governments of Canada and Alberta to make important health care announcement

The Honourable Randy Boissonnault, Minister of Employment, Workforce Development and Official Languages, and the Honourable Patty Hajdu, Minister of Indigenous Services and Minister responsible for the Federal Economic Development Agency for Northern Ontario, on behalf of the Honourable Mark Holland, Canada’s Minister of Health, along with the Honourable Adriana LaGrange, Minister of Health for Alberta, will make an important announcement on seniors’ health care.

Statement from the Minister of Mental Health and Addictions and Associate Minister of Health

The overdose crisis is one of the most serious and unprecedented public health threats in Canada’s recent history. It is driven by the illegal drug supply, which is unpredictable, rapidly changing and growing increasingly toxic. To address this crisis, we need a full continuum of supports across prevention, harm reduction, treatment, and enforcement, while ensuring a careful balance between public health and public safety.

INDIA

Withdrawal of indication for Olaparib Tablets 100mg and 150mg in the treatment of patient with gBRCA mutution and advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy

The Olaparib Tablets 100mg/150mg was initially approved by this office in 13.08.2018 for following indications:

Ovarian cancer:

• For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
• For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Breast cancer:

• In patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment.

MALAYSIA

Application Forms Biologics

The site has updated new application forms for Biologics.

https://npra.gov.my/index.php/en/component/content/article/159-english/application-form-biologics/1527063-application-forms-biologics.html?Itemid=1391

Revision of timelines for variation applications of registered products [pharmaceutical products & natural and health supplement products (TMHS)] and a pilot study

For information, NPRA is continuously working towards improved efficiency, not only for pre-marketing product assessments but also for post-approval changes. To provide greater clarity and more effective monitoring, we are in the plan to revise the current timelines for variation applications outlined in the Malaysian Variation Guideline for Pharmaceutical Products (MVG), Malaysian Variation Guideline for Biologics (MVGB), and Malaysian Variation Guideline for Natural and Health Supplement Products.

SINGAPORE

Updates on reclassified medicines

The following forensic classifications describe the three levels of access controls for therapeutic products in Singapore:

Prescription Only Medicines (POM): A therapeutic product that can only be obtained from a doctor or a dentist, or from a pharmacist with a prescription from a doctor or a dentist. The condition to be treated needs to be diagnosed and treated by a doctor. It can also have serious side effects which require a doctor’s monitoring or follow up.

Pharmacy Only Medicines (P)*: A therapeutic product that can be obtained from a pharmacist at a retail pharmacy. The condition is self-limiting and can be assessed and treated by pharmacists.

General Sale List (GSL): A therapeutic product that can be freely obtained from any retailer. It can be used safely by the public without medical supervision and intended for short term self-treatment only.