Tagged with Biosimilar

USA Christine Baeder, President of USA and LATAM at Apotex, discusses the company’s evolution following private equity investment, its Generics Plus strategy, and the critical role of the US market. She highlights supply chain resilience, the challenges facing biosimilar adoption, and the need for structural policy reforms to sustain affordability, innovation…

USA 2026 could mark a turning point for biosimilar adoption in the US. By scrapping requirements for redundant clinical trials and pushing Congress to end the “Interchangeable” label, the FDA has cleared the runway for biosimilars. However, with PBM “rebate walls” and patent thickets still standing, will these lower cost therapies…

USA The FDA’s Sarah Yim discusses the evolving regulatory landscape for biosimilars in the US, the shift toward analytical-heavy reviews over large clinical studies, the legislative push to simplify interchangeability, and the agency’s commitment to increasing market competition and patient access through streamlined development pathways. My goal, and the FDA goal…

USA John Murphy III, President and CEO of the Association for Accessible Medicines (AAM), argues that 2026 represents a pivotal moment for the United States to reclaim leadership in biosimilars. He outlines how recent FDA reforms could finally unlock competition, lower drug costs, and expand patient access, while warning that outdated…

Taiwan Will Hsu leads Sandoz operations across Taiwan, Hong Kong, and Macao, managing a portfolio spanning both generics and biosimilars in markets characterised by universal healthcare and significant budget constraints. With nearly 12 years at Sandoz, including three years in his current regional role, Hsu oversees strategic initiatives to increase biosimilar…

USA Writing in the January 2026 edition of DIA Global Forum, Mariana Socal and Antonio J. Trujillo from the Johns Hopkins Bloomberg School of Public Health and Rachel Goode of Fresenius Kabi argue  that biosimilars could significantly reduce US drug spending and expand patient access, but that their impact is being…

USA Spiro Gavaris, President of Lupin’s US generics business, shares a candid assessment of the shifting dynamics shaping today’s generic and biosimilar landscape. He outlines how Lupin is positioning itself for long-term leadership through focused investment in complex generics across inhalation technologies, injectables, and biosimilars, while navigating a market challenged by…

France At a time when France’s healthcare landscape is being reshaped by regulatory change, market pressure, and shifting patient expectations, Fabrice Ruggeri, Country Manager of Organon France, is steering the affiliate through a new phase of purposeful growth. Under his leadership, Organon France is strengthening its long-standing commitment to women’s health…

USA John Murphy, III, president & CEO of the Association for Accessible Medicines (AAM) lays out a stark warning: the very medicines that keep the US healthcare system affordable and functioning are at risk. Generics and biosimilars fill nine out of ten prescriptions yet account for a tiny slice of spending,…

LatAm Gianclaudio Broggi is CEO and chairman of Megalabs, one of Latin America’s largest biopharma organisations with operations spanning more than 20 countries and a workforce exceeding 9,000 employees. With over two decades at the company, he has been instrumental in its transformation from a 120 million USD enterprise into a…

France At the helm of EG Labo (STADA Group), Tiago Bartolomeu is steering one of France’s leading accessible medicine players through a period of renewal and ambition. With a clear focus on expanding access through generics, biosimilars, and consumer health, he reflects on the company’s growth strategy, its role as a…

USA Thomas Nusbickel, Chief Commercial Officer, describes how Celltrion, founded over 20 years ago, pioneered biosimilars through a fully integrated business model. Its US office opened in 2018 and has since transitioned from partnerships to direct sales, launching several biosimilars in oncology, immunology and endocrinology. With a strong pipeline, a growing…