- SIILTIBCY® is poised to be the first skin test in Europe that accurately detects TB, regardless of BCG vaccination status
- EMA has given a positive recommendation, with a final decision on marketing approval expected by the end of 2024.
- Recommendation is based on comprehensive manufacturing and clinical data showing the accuracy and safety of SIILTIBCY®
- SIILTIBCY® will be ready for shipment to EU Member States immediately following authorization by the European Commission
- This collaboration marks a significant milestone for the Cyrus Poonawalla Group of companies – SLS Europe, Bilthoven Biologicals, and Serum Institute of India – to deliver innovative solutions for Tuberculosis infections
Bilthoven (The Netherlands) – Hannover (Germany), October, 23, 2024 – Serum Life Science Europe GmbH (SLS Europe), a pharmaceutical development company and Bilthoven Biologicals (BBio), a vaccine manufacturer, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending authorisation of SIILTIBCY®, the diagnostic test for tuberculosis (TB) infection in adults and children aged 28 days or older.
The European Commission (EC) will review the CHMP recommendation, with a final decision anticipated in the fourth quarter of 2024. SIILTIBCY®, already marketed in India as Cy-Tb, is manufactured by Serum Institute of India to ensure supply readiness in Europe and globally. Following the EC decision, the diagnostic test will be available to applicable EU Member States. SLS Europe will be the Marketing Authorization Holder, while BBio will import, release, and market SIILTIBCY®.
The positive CHMP opinion is based on a comprehensive review of manufacturing, development and clinical trial data supporting the accuracy and safety of SIILTIBCY®. This assessment is informed by results from three pivotal Phase 3 clinical trials involving over 2,500 participants across Europe and Africa, which demonstrated the test’s effectiveness for diagnosing TB. Trial findings were published in reputable medical journals, including The Lancet Respiratory Medicine.
Adar Poonawalla, CEO of Serum Institute of India, remarked, “The positive CHMP opinion for SIILTIBCY® is a watershed moment in our fight against tuberculosis. This skin test, developed through years of research, addresses a critical gap in TB diagnostics by providing accurate results regardless of BCG vaccination status. As we prepare to introduce SIILTIBCY® to the European market, we’re offering a powerful new tool that could support global eradication efforts. This milestone underscores our commitment to developing innovative, affordable solutions for pressing global health challenges.”
“The EMA’s positive opinion for SIILTIBCY® represents a crucial advancement in the fight against TB,” said Leander Grode, Managing Director of SLS Europe. “By strengthening diagnostic capabilities, we are taking significant strides toward supporting public health initiatives and aligning with global efforts to eradicate TB.”
“Traditional TB skin tests often produce false-positive results in BCG-vaccinated individuals due to cross-reactivity. By providing a reliable and precise diagnostic test, we are empowering healthcare professionals to make better-informed decisions, contain the costs of diagnosis and ultimately save more lives,” said Jurgen Kwik, Chief Executive Officer of BBio. “We welcome the positive opinion for SIILTIBCY®and are working towards making the diagnostic available across Europe.”
The expected approval of SIILTIBCY® signifies the first collaboration for European product introductions between sister companies SLS Europe, BBio, and Serum Institute of India which are part of the Cyrus Poonawalla Group. In this partnership, SLS Europe will serve as the Marketing Authorization Holder, overseeing regulatory compliance and product safety. BBio will import, release, and market SIILTIBCY® across the EU Member States. The Serum Institute of India, the world’s largest vaccine manufacturer by doses produced and sold globally, has been responsible for manufacturing SIILTIBCY® to ensure supply readiness both in Europe and worldwide.
