Biocon Biologics receives EU marketing authorisation for Vevzuo and Evfraxy biosimilars of Denosumab
Vevzuo is authorised for the prevention of bone complications in adults with advanced cancer involving bone and the treatment of adults and skeletally mature adolescents with giant cell tumour (GCT) of bone.
Evfraxy is authorised for the treatment of osteoporosis in men and postmenopausal women, the treatment of bone loss linked to hormone ablation in men with prostate cancer at increased risk of fractures or treatment of bone loss associated with long-term systemic glucocorticoid therapy in adults.
Clinical data showed that both Denosumab biosimilars have comparable quality, safety, and efficacy to the reference product.
The marketing authorisation follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on 25 April 2025.
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Hindustan Times
10 hours ago
- Hindustan Times
'My comments were in haste', says Kiran Mazumdar-Shaw after CM Siddaramaiah's clarification
Biocon chief Kiran Mazumdar-Shaw has clarified her stance on Covid-19 vaccine approvals, stating that her earlier remarks may have been made in haste, while reiterating her confidence in the rigorous processes followed for vaccine approval in India. Shaw's earlier post had strongly defended the vaccine approval process in India.(PTI File Photo) Responding to Karnataka Chief Minister Siddaramaiah's recent statement on the government's intent behind probing a spate of sudden deaths in Hassan district, Shaw wrote on X, 'I agree with Hon CM @siddaramaiah re asking questions n seeking answers in science. However, my comments related to whether Covid vaccines were approved in haste n my response was that due process was followed as prescribed by WHO for safety n efficacy for EUA. Losing lives in a sudden manner is always tragic n I am glad an investigation is being conducted in Hassan District.' Read her full post here: Her remarks come after Siddaramaiah defended his decision to order an inquiry into recent heart-related deaths in Hassan, many of which affected young individuals. In a detailed response posted online, the Chief Minister clarified that his comments were not meant to question the science behind Covid-19 vaccines, but to address the genuine concerns of families who had lost loved ones unexpectedly. 'Seeking clarity is not misinformation; it is an act of governance rooted in empathy,' Siddaramaiah wrote, adding that while vaccines saved lives, scientific literature has acknowledged rare but serious side effects, including cardiac events. He cited admissions by vaccine manufacturers like AstraZeneca, and peer-reviewed studies in reputed journals discussing vaccine-linked myocarditis and cardiac arrest, especially among young adults. Shaw's earlier post had strongly defended the vaccine approval process in India, calling suggestions of hasty clearances 'factually incorrect' and potentially harmful. 'These vaccines have saved millions of lives and, like all vaccines, may cause side effects in a very small number of individuals,' she had written, urging public discourse to remain rooted in science and evidence. (Also Read: Siddaramaiah responds to Kiran Mazumdar-Shaw's criticism, says 'Seeking answers is our duty, not blame')
India Today
12 hours ago
- India Today
Siddaramaiah, Biocon founder spar over vaccine safety amid rise in Hassan deaths
A public exchange between Karnataka Chief Minister Siddaramaiah and Biocon founder Kiran Mazumdar Shaw has brought national attention to the state's investigation into a series of sudden deaths in Hassan district. The debate between the two public figures is centred on whether Covid-19 vaccines might be linked to the rise in heart-related her latest post on July 4, the Biocon founder while agreeing with the Chief Minister's position on seeking scientific clarity reiterated that vaccines developed in India were approved through due process. advertisement'My response was that due process was followed as prescribed by WHO for safety and efficacy for EUA. Losing lives in a sudden manner is always tragic and I am glad an investigation is being conducted in Hassan district,' she wrote on X. This came in response to Siddaramaiah's post on July 3 on the social media platform, where he clarified that asking questions about vaccine safety was a governance responsibility, not misinformation. 'When parents lose their young children or families lose breadwinners without warning, seeking clarity is not misinformation; it is an act of governance rooted in empathy.' Citing multiple peer-reviewed studies, he added that some Covid-19 vaccines had been linked to rare cardiac events, and that global regulators, including the World Health Organisation (WHO), had acknowledged the emergency rollouts involved 'calculated risks'.Siddaramaiah defended his earlier remarks on July 1 suggesting that 'hasty' vaccine approvals could not be ruled out as a factor in the increase in heart attacks. 'It cannot be denied that the hasty approval and distribution of the Covid-19 vaccine to the public could also be a reason for these deaths, as several studies worldwide have recently indicated,' he had Shaw had earlier countered that Indian vaccines were approved under the Emergency Use Authorisation framework, adhering to international safety and efficacy norms. 'To suggest that these vaccines were 'hastily' approved is factually incorrect and contributes to public misinformation,' she wrote on July 3. 'These vaccines have saved millions of lives and, like all vaccines, may cause side effects in a very small number of individuals.'In response, Siddaramaiah stated, 'Haste is not a sin when saving lives, but acknowledging potential unintended consequences is wisdom.' The Chief Minister's comments followed reports that more than 20 people had died of heart attacks in Hassan district in the past month. In response, the state government has formed a high-level expert committee under Dr Ravindranath, Director of the Jayadeva Institute of Cardiovascular Sciences and Research, to investigate the deaths and submit a report within ten is the same panel that was tasked in February 2025 with studying the cause of sudden deaths among young people in Karnataka and whether there could be any link to Covid-19 vaccination. Siddaramaiah said the panel would continue evaluating cardiac cases and deliver its findings, based on which the government would take further action.'We too value the lives of children, youth, and innocent people who have their entire lives ahead of them, and we share the concerns of their families,' he said. He also condemned the BJP for allegedly politicising the deaths. 'Before BJP criticise us on this matter, they should ask their conscience,' he said.- Ends IN THIS STORY#Karnataka
The Hindu
14 hours ago
- The Hindu
Karnataka CM's remarks on Covid vaccines 'factually incorrect' says Biocon chief Kiran Mazumdar-Shaw, Siddaramaiah hits back
Biocon founder Kiran Mazumdar-Shaw on Thursday (July 3, 2025) opposed Karnataka Chief Minister Siddaramaiah's remarks linking Covid-19 vaccines with a spate of heart attack deaths in the state's Hassan district, saying such claims are 'factually incorrect' and 'misleading'. Siddaramaiah had suggested that the recent heart attack deaths in Hassan district may be linked to the vaccination drive. He had also claimed the vaccines were 'hastily' approved. COVID-19 vaccines developed in India were approved under the Emergency Use Authorisation framework, following rigorous protocols aligned with global standards for safety and efficacy. To suggest that these vaccines were 'hastily' approved is factually incorrect and contributes to… — Kiran Mazumdar-Shaw (@kiranshaw) July 3, 2025 In a social media post, Shaw said 'Covid-19 vaccines developed in India were approved under the Emergency Use Authorisation framework, following rigorous protocols aligned with global standards for safety and efficacy. To suggest that these vaccines were 'hastily' approved is factually incorrect and contributes to public misinformation.' "These vaccines have saved millions of lives and, like all vaccines, may cause side effects in a very small number of individuals. It is important to acknowledge the science and data-driven processes behind their development, rather than engage in retrospective blame," Shaw, Executive Chairperson of the pharma company, said. Not misinformation, but governance rooted in empathy Responding to Shaw, in a post on X, Siddaramaiah said that as chief minister, 'I have a duty to respond to the genuine concerns of people who have lost loved ones unexpectedly. When parents lose their young children or families lose breadwinners without warning, seeking clarity is not misinformation; it is an act of governance rooted in empathy.' Pointing out that several studies and even admissions by manufacturers have acknowledged rare but serious adverse events, he said 'Scientific caution is not anti-science. Many peer-reviewed studies (such as Nature, Circulation, Journal of the American College of Cardiology) have discussed myocarditis and cardiac arrest risk, particularly among young adults post-vaccination, he said. Publicly funded stakeholders must acknowledge both the benefits and the potential risks without fear or favour.' "When I said 'hastily', it reflects the unprecedented speed of emergency rollouts globally without complete long-term data, acknowledged even by WHO and global regulatory agencies, who termed it a 'calculated risk' during a pandemic. Haste is not a sin when saving lives, but acknowledging potential unintended consequences is wisdom. Seeking answers is not retrospective blame. It is the duty of a government that values every life," the CM said. As Chief Minister, I have a duty to respond to the genuine concerns of people who have lost loved ones unexpectedly. When parents lose their young children or families lose breadwinners without warning, seeking clarity is not misinformation; it is an act of governance rooted in… — Siddaramaiah (@siddaramaiah) July 3, 2025 Replying to his post again, Ms. Shaw said that while she concurs with the CM about asking questions and seeking answers in science, she clarified that her comments were related to whether Covid vaccines were approved in haste. 'My response was that due process was followed as prescribed by WHO for safety n efficacy for EUA. Losing lives in a sudden manner is always tragic n I am glad an investigation is being conducted in Hassan District (sic),' she said. CM's statement The Chief Minister had said on July 1 that over 20 people had died of heart attack in Hassan district in the past month alone, and that the state government was taking the matter seriously. He announced the formation of an expert committee led by Dr. Ravindranath, Director of Jayadeva Institute of Cardiovascular Sciences and Research, to investigate the deaths. The committee has been instructed to submit its report within ten days. The CM said a similar directive had been issued in February to study sudden deaths among young people across the state and whether Covid-19 vaccines could have had any adverse effects. "It cannot be denied that the hasty approval and distribution of the covid vaccine to the public could also be a reason for these deaths, as several studies worldwide have recently indicated that covid vaccines could be a cause for the increasing number of heart attacks," Siddaramaiah had said. Union Health Ministry's clarification On Wednesday (July 2), the Union Health Ministry had dismissed the CM's statement, saying extensive studies by ICMR and AIIMS have conclusively established no linkages between coronavirus vaccines and sudden deaths. Studies by the Indian Council of Medical Research (ICMR) and National Centre for Disease Control (NCDC) affirm that Covid-19 vaccines in India are safe and effective, with extremely rare instances of serious side effects, it said. Sudden cardiac deaths can result from a wide range of factors, including genetics, lifestyle, pre-existing conditions, and post-covid complications, the ministry had said in a statement.
