Thelansis

The regulatory landscape for biosimilars is shifting significantly in 2025. The FDA has taken two big steps that collectively make it faster and cheaper to bring many biosimilars to market: In June 2024, the FDA proposed to drop “switching” studies for the interchangeable designation, saying most products won’t need extra human trials just to prove patients can switch back and forth. In October 2025, the FDA issued new draft guidance signaling that comparative efficacy trials may often be unnecessary for showing biosimilarity, putting more weight on analytics, PK/PD, and totality of evidence. The FDA also previewed steps to make interchangeability more straight forward. Those two moves won’t solve every commercial hurdle, but they materially reduce development burden. Below is a breakdown of the key policy changes, what they mean for different players, and how each region might respond. United States: Simpler files, but access still decid...

Introduction: Licensing as a Growth Engine in Pharma The global pharmaceutical and biotech companies are entering an era of collaboration, agility, and strategic alliances. As the R&D cost rises and regulatory timelines stretch, licensing deals have become essential levers for pharma companies to drive innovation and market expansion. Recent data indicate that 68% of blockbuster drugs are now sourced from licensing agreements instead of being developed in-house. In 2025, the focus is shifting from transactional licensing to value-based partnerships. Pharmaceutical leaders are faced with a decision: should they acquire promising compounds from biotech companies or license out their own assets to enhance profits? As this choice will influence the future direction of their companies for years ahead. Understanding In and Out Licensing In-licensing allows companies to acquire external innovations, be it a molecule, technology, or platform, to strengthen their product pipeline wi...

Europe’s pharmaceutical landscape is undergoing a significant change due to its medicine shortage problem, which has a stubborn root cause: fragile upstream links. The situation becomes apparent at the pharmacy counter, but it originates much earlier, at the level of raw materials, intermediates, and APIs, which are overwhelmingly sourced outside the EU. Recent audits and policy moves acknowledge this head-on; the European Court of Auditors (ECA) pointed out chronic shortages through 2024, driven by dependence on Asian suppliers and thin market incentives, as more than 80% of antibiotic APIs used in Europe are imported from Asia. Over the last 18 months, Brussels has moved from diagnosis to action. There’s now a Union List of Critical Medicines updated in December 2024, and HERA has published a vulnerability assessment for that list. In March 2025, the Commission proposed the Critical Medicines Act with tools such as strategic projects, stockpiling, and supply chain transparency. Mem...

In the fast‐moving world of biopharma innovation, it’s easy to get excited by the science – the novel target, the breakthrough molecule, the cutting-edge modality. But amid that excitement, one strategic document often gets overlooked or relegated to a checkbox: the Target Product Profile (TPP). Too often, teams pour years of effort and resources into a promising molecule, only to realize late in the process that what they’ve built isn’t quite what the regulators, payers, or patients actually needed. That’s a missed opportunity, because when used right, a well-crafted TPP doesn’t just guide development. It connects science with strategy, aligning every function — from R&D and regulatory to commercial and manufacturing — around one clear vision of what success should look like. What Exactly Is a TPP? At its core, a Target Product Profile (TPP) is a living blueprint that defines the intended attributes of a future therapeutic product. It outlines key elements like indication, pat...

The U.S. healthcare system never really sits still but 2026 is shaping up to be a year where cost, access, and innovation intersect in new and sometimes uncomfortable ways. From the Inflation Reduction Act’s pricing negotiations to the quiet but powerful spread of value-based models, the rules that govern how therapies reach patients are being rewritten. Below are eight themes we believe will define the next phase of U.S. market access and each carrying very real implications for patients, payers, providers and drug/biotech innovators. 1. Medicare price negotiations move from theory to practice The Inflation Reduction Act (IRA) has already changed boardroom conversations around pricing and lifecycle management, but in 2026 the negotiated prices will finally start taking effect. Manufacturers will face tighter margins on some of their most commercially critical assets. For patients, this could mean lower out-of-pocket costs on selected drugs, but also narrower formularies or ste...

With the healthcare landscape shifting rapidly, teams across biopharma, consulting, med-tech, and healthcare strategy face a common bottleneck: turning scattered epidemiology data, literature, real world data and competitive signals into clear, actionable insights. Epidemiology remains the backbone of clinical development, commercial planning, medical strategy, and portfolio decision-making but in most organizations, the data is still fragmented, inconsistent, or slow to update. EpiLansis, an AI-powered epidemiology and forecasting platform by Thelansis, was designed to address the pain points. Built for scientific, commercial, and strategy teams, EpiLansis brings together real-time epidemiology data, global disease burden matrix, potential patient funnel, treatment landscapes, patient journey analytics, and disease burden insights— all in one cloud-based environment. With 350+ indications, 35+ global markets, and a robust AI-driven research engine, the platform empowers teams to...