Tagged with tech

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Are there any Managed entry agreements in place in your country? (If so, please list them) The first public and only managed access agreement reported in Brazil was signed between the Ministry of Health…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Which are the main actors involved in public procurement and tendering? As mentioned in Chapter 2, Question 7, each entity of public administration is able to carry out public procurement and tendering in order…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Please describe the main cost containment policies in place in your country and their fundamental principles a. Pricing and impact of generic/biosimilar approval Generic drugs must have their PF 35% cheaper than the corresponding…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Has an essential or priority drug list been published in your country? (If so provide the link)   Yes. In Brazil, the National List of Essential Drugs (“RENAME”) provides the selection and standardisation of…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What is the definition of an orphan drug in your country? There is no specific definition for orphan drug in Brazilian current rules. However, we understand that it corresponds with the definition of rare…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What is the definition of a vaccine in your country? As per ANVISA Resolution RDC 55/2010, vaccines are immunobiological drugs which contain one or more substances (antigens) that, when injected into an individual, stimulate…

China No longer a fledgling biotech, oncology-focused BeiGene, originally created in China in 2010 with the idea of carrying out world-class research there, has since expanded its global reach and garnered approvals for its therapies Brukinsa and Tevimbra. The company is on a growth trajectory with product sales reaching USD 2.2…

India Multinational life science firms have been present in India for decades. However, they have often eschewed bringing their latest products to a country that has long prioritised affordability above innovation. Now though, as India’s GDP and market value soar and the policy environment shifts towards prioritising the domestic development of…

India Terumo India’s Shishir Agarwal outlines the company’s strategic roadmap and growth trajectory in India, highlighting the organization’s focus on understanding the healthcare landscape, enhancing organizational capabilities, and diversifying the product portfolio. This approach has enabled Terumo to navigate the competitive landscape successfully and achieve substantial market share, even amidst challenges…

China The biggest pharma industry stories coming out of China, including the impact of the US Biosecure act on Chinese giants WuXi AppTec and WuXi Bio; Novartis’ acquisition of SanReno Therapeutics; the first orphan drug designation for a Chinese herbal medicine-based therapy, and AstraZeneca’s new production line in Taizhou.   Eisai…

Saudi Arabia As the GCC’s largest market, Saudi Arabia, with its growing population, strong healthcare infrastructure and government commitment to developing the economy beyond oil through its Vision 2030, is increasingly attractive for multinational pharma and local players alike. In 2024 government reforms will continue to encourage investment and local production while…

Europe Obesity is pharma’s new El Dorado. Following the spectacular market success and sky-high sales projections of next-generation obesity treatments, many actors – both large and small – are looking to carve out a slice of this huge growth market. Those who made a bet on obesity years in advance are…