The global biopharma landscape reached a historic milestone in 2026. Exactly 20 years after the world’s first regulatory approval of a biosimilar — the landmark 2006 European approval of somatropin, a recombinant human growth hormone — the major regulatory domains of Europe (EMA) and the United States (FDA) reached a combined total of nearly 250 biosimilar approvals (as of Q3 2026). This evolution reflects not only significant breakthroughs in analytical characterization, regulatory science, as well as chemistry, manufacturing and controls (CMC), but also a fundamental transformation in how pharmaceuticals are commercialized. To examine the trajectory of this maturing industry, GeneOnline sat down with Dr. Klaus Martin, Senior Vice President, BPBU CEO of EirGenix Inc., and Managing Director of EirGenix Europe GmbH. Having built a distinguished career spanning over two decades that directly parallels the rise of follow-on biologics, Dr. Martin shares his expert analysis on the shift toward market genericization, …

Thriving in a Genericized Biosimilar Market: Winning with Cost Efficiency, Differentiated Portfolios and Global Partnerships Read More »

As the global number of cancer cases keeps rising and patients are getting younger, high unmet medical needs persist, fueling the development of novel treatment modalities such as antibody-drug conjugates (ADCs). Combining the precise targeting of antibodies with the potent cytotoxicity of chemotherapeutic agents, ADCs have emerged as a key component in cancer treatment in recent years, seeing rapid market growth. Yet achieving clinical and commercial success with an ADC requires not only innovative antibody design and effective antibody–payload combinations, but also the integration of CMC capabilities, conjugation technology, GMP manufacturing, and a robust cross-border supply chain. As a leading CDMO in Taiwan, Mycenax Biotech has recognized this trend and is advancing its ADC CDMO ecosystem. On July 14, 2026, the company hosted the “2026 Emerging Biologics Summit Asia” in Taipei, aiming to harness expert wisdom and insights to navigate the diverse challenges in ADC R&D and manufacturing. The event …

Mycenax Teams Up with Global Partners to Expedite R&D and Market Launch of Next-Generation ADCs Read More »

When thinking about how living things work, most people picture a simple genetic code. All life on Earth uses four basic building blocks to write every biological instruction. For decades, scientists believed this four letter limit was a fixed rule of nature. They assumed living cells could only read and copy these natural letters. However, recent breakthroughs in synthetic biology challenge this traditional boundary. Backed by single-cell genomic analysis, researchers at University of California San Diego (UC San Diego) show in a recent press release that cellular machinery can handle double the information. The bodies of simple bacteria can process an artificial eight letter system without breaking down. They actively use expanded genetic code to build functional molecules that do not exist in nature. This discovery shifts views about how the chemical limits of life itself change. The Expanded Code: Retraining Cellular Machinery for Synthetic Alphabets To understand this process, …

Expanding Biology’s Frontier: Cellular Machinery Successfully Reads an Eight Letter Genetic Alphabet Read More »