Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not considered the same as generic medicines. According to the Health Sciences Authority of Singapore (“HSA”), biologics are medicinal products with large complex molecules produced by living cells through highly specific processes. Even a…
Spain A roundup of the biggest stories emerging from Spain’s pharma industry: Grifols pushes to improve governance after accusations of overstated earnings; Rovi and Insud join forces to create Spain’s first semi-public pharmaceutical company; Almirall and Eloxx Pharmaceuticals sign a licensing agreement for a rare dermatological disease asset, and Esteve acquires…
China Since first establishing an affiliate in China back in 2017, Gilead Sciences has been able to introduce 11 innovative medicines to the Chinese market – eight of which have been included in the National Reimbursement Drug List – across HIV prevention & treatment, viral hepatitis, invasive fungal disease, and cancer.…
USA Since its establishment in 2003, the US President’s Emergency Plan for AIDS Relief (PEPFAR) has saved over 25 million lives and drastically reduced HIV infection rates through antiretroviral treatments. Now well established as the leading global funder of HIV prevention efforts, PEPFAR is supporting high HIV burden countries to meet…
UAE Long-established as the Middle East and Africa’s leading country in terms of rapid access to biomedical innovation, the UAE is looking to bolster this positioning in the coming years. Indeed, allowing innovation to flourish – including through hosting greater numbers of clinical trials in the country and protecting intellectual property…
China Jimmy Wei founded Chime Biologics over 12 years ago with the vision of establishing a global biologics company in China, focusing on biosimilar development and CDMO services. The company’s growth since then has been influenced by the success of other biologics companies like WuXi Biologics and Samsung Biologics, regulatory changes…
Global The US National Institutes of Health (NIH) is the largest public investor in HIV/AIDS research globally. This means that, as Director of the Division of AIDS (DAIDS) at the NIH’s National Institute of Allergy & Infectious Diseases (NIAID) Dr Carl Dieffenbach oversees a global HIV/AIDS research portfolio of more than…
Mexico While the COVID-19 pandemic revealed vulnerabilities that sent many organizations looking for ways to bring supply chains closer to home, geopolitical tensions have also encouraged companies to avoid dependence on China. MedTech, like the automotive sector, is turning to Mexico where it can easily reach the vast North American market…
Middle East & Africa Roula Youssef Halabi, SVP Global Fertility Services, discusses her six-year journey at CooperSurgical, establishing a footprint in the Middle East, overcoming cultural biases as a female executive and the shift that has led GCC countries to increasingly recognize the importance of women’s health. She also speaks about the need for…
Global Marijn Verhoef, Director of Operations and Research at the Access to Medicine Foundation examines the interconnected challenges of drug shortages and antimicrobial resistance. Verhoef urges decisive and urgent action from the pharma companies that manufacture lifesaving antibiotics and antifungals to ensure that patients can get the right medicine when they…
India Managing Director Dr Sharvil Patel outlines the objectives behind the rebranding of the Indian pharma company from Zydus Cadila to Zydus Lifesciences, provides insights into the importance of the US generics market where it launches some 30 to 40 products per year, and Zydus’ newfound focus on innovation with a…
France Lionel Collet, president of France’s Haute Autorité de Santé (HAS), explains the role of the independent public authority, which extends beyond health technology assessment (HTA) to clinical practice guidelines and certifying hospitals, and its unique position as a separate body outside of the Ministry of Health. He describes France’s early…
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