Serum - Protection from birth onwards
Pune (India) - Hannover (Germany) – Bilthoven (The Netherlands), February 18, 2025 - Serum Institute of India Pvt. Ltd. (SIIPL), a global leader in the vaccine manufacturing, along with its sister companies SLS Europe (Serum Life Science Europe GmbH) and BBio (Bilthoven Biologicals), which are part of the Cyrus Poonawalla Group, announce that SIILTIBCY®, a novel tuberculosis (TB) diagnostic test, has received full marketing authorisation from the European Commission (EC). This authorisation is based on a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP).
SIIPL India, has earlier received the EU GMP certification for SIILTIBCY®, Drug Substance and Drug Product manufacturing facilities, located at Pune India.
SIILTIBCY®, developed and manufactured by Serum Institute of India, is indicated as a diagnostic aid for detection of Mycobacterium tuberculosis infection, including disease, in adults and children aged 28 days or older. Intended for diagnostic use only by healthcare professionals, SIILTIBCY® will be presented as a solution for intradermal injection containing Mycobacterium tuberculosis-derived antigens (rdESAT-6 and rCFP-10). Intradermal administration of these antigens induces a delayed-type hypersensitivity reaction in individuals carrying the bacteria, visible as an induration at the site of injection.
The EC’s approval follows a comprehensive review of development, manufacturing and clinical data, including results from three pivotal Phase 3 clinical trials across Europe and Africa.
Adar Poonawalla, CEO of Serum Institute of India, said, “The EC approval for SIILTIBCY® is a great achievement for us to combat Tuberculosis; a life-threatening disease. We would also like to recognize the scientific and regulatory strategies and its implementation by our teams for this achievement”. He further emphasized, “In addition to the Indian Marketing Authorisation, this EU approval 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”.
With the EC’s approval, SIILTIBCY® is expected to be distributed across the European Union (EU) and the European Economic Area (EEA) member states starting in the first quarter of 2025 with availability determined by local regulatory requirements and logistical considerations.
In this collaboration within the Cyrus Poonawalla Group; 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 compliance of SIILTIBCYTM for Europe and worldwide.
In continuation to this EC approval, 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 SIILTIBCY®
Active substances: 0.05 µg rdESAT-6 and 0.05 µg rCFP-10 in one dose (0.1 mL).
Indication: Diagnostic aid for the detection of Mycobacterium tuberculosis infection, including disease, in adults and children aged 28 days or older. For diagnostic use only.
Contraindications: Hypersensitivity to the active substances or any of the excipients. Hypersensitivity to Lactococcus lactis. Severe local or systemic reaction to other Mycobacterium tuberculosis derived products.
Side effects: The most common side effects include pruritus, pain, and hematoma at the injection site.
SIILTIBCY® is a skin test, indicated in the EU and EEA countries for diagnosing TB infection, in adults and children aged 28 days or older. SIILTIBCY® cannot be used as stand-alone tool for diagnosis of active tuberculosis disease. In addition, risk assessment, radiography, and other diagnostic evaluations should be considered for subjects suspected to have active tuberculosis.
Prescription-only. For further information, please refer to the Summary of Product Characteristics (SmPC).
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 Serum Institute of India
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, SII holds the distinction of being the world's largest vaccine manufacturer. SIIPL's multifunctional production and one-of-the-largest facilities in Hadapsar & Manjari, 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 'Pneumosiil,' the world's most affordable PCV, '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, ‘MenFive’, the first in the world Pentavalent (ACYWX) Meningococcal Polysaccharide Conjugate Vaccine, approved and WHO-prequalified for use in the pediatric population. 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, SII has established Serum Life Sciences Ltd, a subsidiary in the UK. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide. www.seruminstitute.com
About SLS Europe
SLS Europe is a pharmaceutical consulting and development company based in Hannover, Germany. Established in 2002, SLS Europe provides strategic expertise in pharmaceutical development, clinical trial management, and regulatory affairs, specializing in guiding biotechnology and pharmaceutical companies through the European and global regulatory landscape. The company supports product development from R&D to commercialization, collaborating with partners to bring innovative products to both European and global markets.
As the Marketing Authorisation Holder, SLS Europe ensures regulatory compliance and oversees the safety and efficacy of its products throughout their lifecycle. SLS Europe is part of the Cyrus Poonawalla Group, enhancing its capacity in the pharmaceutical sector. www.sls-eu.com/
About BBio
BBio is a Netherlands-based end-to-end vaccine manufacturer of viral and bacterial vaccines, with its facilities in Bilthoven - Utrecht Science Park Bilthoven. A carve-out of the former Netherlands Vaccine Institute, it was acquired by Serum Institute of India in 2012 and today employs a little under 500 people.
The company has a long-standing track record in supplying vaccines to European markets and works with global health partners such as UNICEF, PAHO, and WHO & /GAVI. With the manufacturing of polio vaccines, BBio is key contributor to the worldwide program for polio eradication. BBio is part of the EU funded pandemic preparedness program, having ever-warm vaccine manufacturing facilities. Together with SII, BBio offers its unmatched end-to-end vaccine capabilities to vaccine developers and innovators, making affordable vaccines and therapies available worldwide. www.bbio.nl/
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