Pune India; October 30, 2024
Serum Institute of India Pvt. Ltd. (SIIPL) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of SIILTIBCY^® - Mycobacterium tuberculosis derived antigens (rdESAT-6 and rCFP-10) in the European markets.

SIIPL India, earlier this year received the EU GMP certification for SIILTIBCY^® Drug Substance and Drug Product manufacturing facilities, located at Pune. As part of the established approval process, the CHMP positive opinion will be reviewed by the European Commission (EC), following which the marketing authorization will be granted in the European Union (EU) member countries, and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein.

SIILTIBCY^® is recommended to be indicated as a diagnostic aid for detection of Mycobacterium tuberculosis infection, including disease, in adults and children aged 28 days or older. This medicinal product is for diagnostic use only, and the presentation will be available as a solution for injection. The active substances of SIILTIBCY^® are Mycobacterium tuberculosis derived antigens (0.5 μg/mL rdESAT-6 and 0.5 μg/mL rCFP-10). The intradermal presentation of the antigens to the immune system induces a delayed-type hypersensitivity reaction in people carrying the bacteria, seen as an induration at the site of injection.

The diagnostic performance of SIILTIBCY^® (sensitivity and specificity) was compared to two products intended for the diagnosis of Mycobacterium tuberculosis: QuantiFERON TB Gold In-Tube test (QFT, an in-vitro test) and Tuberculin purified derivative (PPD RT23, a test used intradermally like SIILTIBCY^®).

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”.

Dr. Umesh Shaligram, Executive Director of SIIPL added, "The CHMP’s positive opinion for SIILTIBCY^® marks a key advancement in the fight against Tuberculosis, and would like to recognize the scientific and regulatory strategies and it’s implementation by our teams for this achievement”. He further emphasized, "It is another milestone for SIIPL, as we continue to leverage our scientific, manufacturing and quality/regulatory expertise to deliver vaccines and biologicals, for the benefit of population in India and globally".

The CHMP positive opinion of SIILTIBCY^® signifies the first successful collaboration of Serum Institute of India with it’s sister companies SLS Europe (Serum Life Science Europe GmbH) and BBio (Bilthoven Biologicals), which are part of the Cyrus Poonawalla Group. In this partnership, as per the local requirements, SLS Europe will serve as the Marketing Authorization Holder, and BBio will import, release, and market SIILTIBCY^® across the EU Member States. The Serum Institute of India, will continue to be responsible for manufacturing and regulatory compliance of SIILTIBCY^® for Europe and worldwide.

In continuation to this CHMP positive opinion, a Marketing Authorization Application (MAA) for submission to the UK MHRA (Medicines and Healthcare products Regulatory Agency) will be made separately, with the reliance procedure under the IRP (International Recognition Procedure).

About TB
An estimated 2 billion people worldwide are infected with TB and annually 9 million people fall ill with the disease. Although Europe is considered a low incidence region, with over 170,000 TB cases annually, the huge reservoir of TB infection in the world stresses the importance of targeted testing. Targeted testing is one pillar in WHOs End TB Strategy to further lower the incidence of TB.

About the Serum Institute of India Pvt Ltd (SIIPL)
Serum Institute of India Pvt. Ltd, is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SIIPL holds the distinction of being the world's largest vaccine manufacturer. SIIPL's multifunctional production and one-of-the-largest facility in Manjri, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.

Founded in 1966, SIIPL's primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of 'Pneumosil,' the world's most affordable PCV, and 'Cervavac' the first indigenous qHPV vaccine in India, and R21/Matrix-M™, the second malaria vaccine to be authorized for use in children in malaria-endemic regions. Moreover, SIIPL has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.

To further expand its global presence and ensure widespread vaccine availability, SIIPL has established Serum Life Sciences Ltd, a subsidiary in the UK. Through relentless pursuit of innovation, SIIPL continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide. www.seruminstitute.com

Media Requests:
Mayank Sen
+91 9867974055
mayank.sen@seruminstitute.com