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Business Standard
5 days ago
- Health
- Business Standard
Servier India introduces 'Ivosidenib'(Tibsovo®), in India, First-in-class Targeted Therapy in Oncology for Rare IDH1-Mutated AML and Cholangiocarcinoma
VMPL Mumbai (Maharashtra) [India], June 5: Servier India, a subsidiary of the leading French pharmaceutical Servier Group, today announced the launch of Ivosidenib (Tibsovo®), an oral targeted therapy approved in the management of cancer patients with Acute Myeloid Leukemia (AML) and Cholangiocarcinoma, with an isocitrate dehydrogenase-1 (IDH1) mutation. Servier India received the approval on 14th May 2025, from Central Drugs Standard Control Organisation (CDSCO) for the import, sale, and distribution of the medication. Acute myeloid leukemia is a challenging hematological malignancy. Studies indicate that only about 30-40% of AML patients in India receive adequate treatment1, with high mortality rates due to rapid disease progression and infections. Cholangiocarcinomas (CCA) are rare tumours originating from bile duct. Due to their asymptomatic nature they are usually diagnosed when the disease is advanced.2 The announcement marks a significant advancement in management of the mentioned rare and difficult-to-treat cancers in India, addressing a critical unmet medical need. Speaking on the occasion, Mr. Aurelien Breton, Managing Director, Servier India, said, "Our focus is to advance oncology care by bringing innovative, precision medicines to patients who need them the most. By prioritizing access and working to make treatment options affordable to patients, we are dedicated to bridging critical gaps in cancer care across the country. This launch is a significant step forward in our mission to support healthcare providers with targeted treatment options and ultimately improve survival outcomes and quality of life for patients throughout India." IDH1 mutation occurs in approximately 7-14% of AML patients in India3, making targeted mechanisms especially relevant for this subset. "This therapy represents a significant therapeutic option in the treatment of AML and Cholangiocarcinoma. For healthcare professionals, this precision therapy offers a new, effective option that can improve patient outcomes where traditional treatments have limited success. It highlights the benefits of targeted therapy and caliber of innovation in enhancing lives and advancing cancer care in India.", highlighted Dr. Pranav Sopory, Medical and Patient Affairs Director, Servier India. Speaking on the importance of treatment access, Ms. Pratima Tripathi, Commercial Director, Servier India, said: "Our foremost priority is to ensure that the therapy is accessible and affordable to patients across India. We are actively collaborating with healthcare providers, patient advocacy groups, and policymakers to remove barriers and facilitate timely access to this important therapy. Through these partnerships, we are committed to expanding treatment options and making a meaningful difference in the lives of patients." By introducing these advanced therapies, Servier India reaffirms its commitment to advancing innovative cancer treatments that improve clinical outcomes and enhance the quality of life of patients. Disclaimer: This press release is intended solely to share regulatory and medical information regarding the launch; the reference to "Tibsovo" is not intended as a promotional or public advertisement. Use of the therapy is strictly based on a doctor's prescription and clinical discretion. About Servier India Servier India has been committed for over three decades to delivering innovative pharmaceutical solutions that improve the lives of patients and their families across India. Established in 1985 as an affiliate of the leading independent French pharmaceutical Servier Group, the company focuses on therapeutic areas such as Cardiometabolism, Neuroscience, Venous Diseases, and Oncology. Servier India has a strong pan-India presence and a dedicated workforce of around 580 that strives to address critical healthcare challenges with passion and purpose. As part of Servier group operating in over 150 countries, Servier India inherits a rich legacy of scientific excellence and patient-centric innovation. Globally, Servier invests heavily in research and development, focusing on our key therapeutic areas. About Servier Servier is a global pharmaceutical group governed by a Foundation that aspires to serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs. As a world leader in cardiometabolism and venous diseases, Servier's ambition is to become a focused and innovative player in oncology by targeting rare cancers. Headquartered in France, Servier relies on a strong geographical footprint; its medicines are available in close to 140 group achieved a revenue of EUR5.9 billion in 2024. Additional Details on Ivosidenib Internationally, Ivosidenib has already received regulatory approvals in more than 42 countries, including the USA, Europe, China, UAE, and South Korea. In the United States, the US FDA approved it in 2019 as a monotherapy and later in May 2022 as a combination treatment with Azacitidine for patients aged 75 and above, or those who cannot tolerate intensive chemotherapy. The European Medical Agency (EMA) gave its approval in May 2023 for use in patients who are not fit for standard induction chemotherapy. In India, the process moved forward in April 2025, when the Subject Expert Committee (SEC) gave a positive recommendation for Ivosidenib. Following this, the DCGI granted approval for the marketing authorization in May 2025
News18
02-06-2025
- Business
- News18
French Firm Servier Drops Exclusive Deal For Selling High BP Drugs After Chemists' Pushback
Last Updated: After successful mediation by offline chemists, Servier promptly withdrew the agreement – which is seen as a positive step towards preserving the fairness of open trade practices. In a major development impacting the pharmaceutical distribution landscape in India, an Indian arm of French drugmaker Servier has officially withdrawn its exclusive distribution agreement for its anti-hypertensive product line, reverting to conventional distribution practices. The move comes after the apex lobby of offline chemists, All India Organisation of Chemists and Druggists (AIOCD), raised concerns, alleging the potential monopolistic implications of Servier's deal with Entero Healthcare, a supply chain specialist company. AIOCD represents more than 12 lakh chemists and distributors in India, pushing Servier to discontinue the arrangement of supplying certain products via Entero. The majority of the AIOCD's partners refused to sell the drugs sold by the French drugmaker. After facing industry pushback, in a letter dated May 26, 2025, Servier India informed its trade partners that it has 'discontinued exclusive distribution arrangement for anti-hypertensive range of products" with immediate effect. The letter has been seen by News18. This update follows a formal communication by AIOCD on May 28, addressing the issue. The letter detailed how many members of the organisation had expressed concerns over the exclusivity agreement, warning that it could lead to discriminatory trade practices, shortages in essential medications, and the formation of monopolistic structures within the pharmaceutical supply chain. AIOCD, in a letter, said that the organisation mediated with Servier to ensure a fair resolution. 'After successful mediation by AIOCD, the company has promptly withdrawn the said exclusive distribution agreement. This is a positive and encouraging step toward preserving the balance and fairness in our open trade practices," the letter read. The development is being seen as a victory for chemists and druggists across India, many of whom feared market distortions and reduced access to essential medicines due to exclusive arrangements. 'We have had fruitful discussions with AIOCD. Servier India is focused on improving patient access to our quality medicines. We will continue to engage constructively with all stakeholders," Aurelien Breton, managing director, Servier India told News18. Brenton told News18 that he is thankful to AIOCD 'for the constructive dialogue, which allowed us to resolve the matter amicably in the interest of the healthcare community and patients at large." 'Servier is a global pharmaceutical group governed by a nonprofit foundation, committed to making a meaningful social impact for patients and contributing to a sustainable world." Headquartered in France, Servier operates in around 140 countries. Sources close to the development told News18 that, 'Servier's management rushed the distributor appointment, with inadequate market assessment and due diligence. However, now, it has made right decision following the general rules of the Indian pharma trade market." First Published: June 02, 2025, 12:40 IST
