Delivering Affordable Biologic Medicines Worldwide: An Interview with Tanvex Chairman and CEO, Henry Chen

Leveraging their latest win in securing the first FDA approval for a filgrastim biosimilar in Asia, Tanvex BioPharma has showcased itself as a recognized player in the biopharmaceutical industry. In an exclusive interview, Lin-Cheng (Henry) Chen, Chairman and Chief Executive Officer of Tanvex BioPharma, discussed several challenges and elaborated on Tanvex’s market approach. He highlighted the company’s strategic expansion into Contract Development and Manufacturing Organization (CDMO) services, leveraging FDA-approved facilities and adhering to current good manufacturing practice (cGMP) standards. Furthermore, he discussed the BLA  approaches and the structural advantages of the company, while outlining the future direction of focus and the role of ADCs in future production success. 

Addressing Biosimilar Challenges: Tanvex’s Strategic Approaches to Clinical Costs and BLA Hurdles

With a focus on biosimilars and CDMO services, Tanvex has been making significant strides in the biopharma sector. Originally Tanvex focused on biosimilars specifically, only later progressing to the field of CDMO services. In recent years the company has achieved notable milestones, including advancing multiple biosimilar Biologics License Applications (BLAs) and expanding its CDMO services. Chen highlighted these achievements as crucial steps in Tanvex’s mission to deliver affordable biologic medicines to patients worldwide. “Our recent successes in advancing BLAs underscore our commitment to bringing safe, effective, and cost-effective biosimilar alternatives to market,” Chen explained. “Looking ahead, we are focused on furthering our partnerships in biopharma and expanding our capabilities in CDMO services to support the next generation of biologic therapies.” 

In this regard, Tanvex Biologics aims its attention specifically at advancing cancer treatments, primarily working in the realm of biosimilars, with novel biologics taking a passenger seat. Here, the approval of TX01 (Nypozi) now allows the company to focus on bringing its next biosimilar, TX05 (Herceptin biosimilar) to market, which is currently in the submission stage. TX05, or Trastuzumab, is a monoclonal antibody targeting the human epidermal growth factor receptor 2 (HER2) protein, inducing an immune-mediated response that causes internalization and recycling thereof.

However, despite success in the oncology field—a known hotspot for CDMO markets—numerous challenges are faced by industry players across the globe. Often, CDMOs encounter challenges in biologics production due to the inherent variability of living cells, demanding precise process control for consistent quality. Further, securing funding is increasingly becoming based on the ability of the companies to reach certain milestones, which directly affects workflow and productivity. Here Chen emphasized that enlisting a CDMO early in the development lifecycle is crucial, as it facilitates biopharmas in securing funding. 

Tanvex’s Dual-Location Strategy Integrates Taipei and San Diego Operations for Early and Late-Stage Developments

Examining the challenges CDMOs face reveals how the company’s current structure positions itself to readily overcome these obstacles. Explaining Tanvex’s operational setup, Chen detailed the company’s strategic division between its headquarters in Taipei and its operations hub in San Diego. The Taipei Center conducts research and early-stage development, utilizing Taiwan’s robust biomedical ecosystem and talent pool that exhibits expertise in biopharmaceutical research and development. Meanwhile, the San Diego facility focuses on clinical development and commercialization, ensuring their products meet global regulatory standards and market demands. This two-way approach combines the strengths of both locations, enhancing efficiency and success in bringing new treatments to market. 

“Our operational structure is dual-location, with the front-end operations, including cell line development, based in Taipei. This initial phase lays the foundation for later-stage development and clinical trials and regulatory approvals conducted in San Diego.” 

Navigating Regulatory Challenges Across Regions: FDA Compliance & Tech Transfers 

Understanding the operational structure enables Tanvex to navigate numerous regulatory challenges across regions. Here, Chen discussed the regulatory landscape that Tanvex moves within, particularly with regard to operations spanning the APAC region and the United States. “Regulatory compliance is a cornerstone of our operations, especially in the biologics and biosimilars sectors,” Chen emphasized. “Harmonizing regulatory standards across regions like APAC and the US presents challenges, but our proactive approach and rigorous compliance strategies enable us to streamline processes and accelerate product approvals.”

While transferring technology between Taipei and San Diego has been relatively straightforward, Chen asserts that complying with the FDA’s rigorous requirements for biosimilar approvals remains difficult. One of the most common challenges faced by CDMOs in the field of biologics and biosimilars involves meeting the stringent standards set by the FDA. The FDA demands extensive clinical data to demonstrate the similarity of biosimilars to original biologic drugs, which creates financial and logistical challenges, particularly because the market for biosimilars is smaller compared to that for new, innovative biologics. Thus, despite the clear Northstar, Tanvex faces specific challenges with biosimilars, particularly regarding the high clinical costs associated with bringing them to market through BLA approval and ensuring molecular similarity. These hurdles present significant obstacles for the company. 

“The FDA’s emphasis on demonstrating similarity to originator molecules through extensive clinical data poses financial and logistical challenges, especially for smaller markets like biosimilars compared to innovator biologics.”

Capitalizing on Biologics Manufacturing Complexity with BLA Despite FDA Hurdles

However, although FDA regulations aim to facilitate biosimilar approvals over time, the rigorous nature of the BLA process remains a significant barrier. Unlike generics, which can be chemically identical, biosimilars are inherently variable in composition due to their biological nature, posing ongoing challenges in defining similarity criteria. This variability requires the FDA to carefully balance approval standards to ensure safety and efficacy while encouraging market competition.

As explained by Chen, “Tanvex is focused on the CDMO side, particularly in biologics, where we excel as a meticulous biosimilars developer in biopharma.” Here Tanvex offers several distinct advantages in the CDMO sector that offer it a competitive edge. This includes holding an FDA certification for its GMP production site, a rarity among CDMOs in the U.S. This certification demonstrates Tanvex’s capability to support biotech companies from early clinical phases through to potential FDA approval, assuring that manufacturing standards meet regulatory requirements.

Moving Forward Going All In on ADCs

Tanvex BioPharma has traditionally concentrated on developing biosimilars, which are biologic medical products highly similar to already approved reference products. This strategic focus aligns with Founder, and Honorary Chairman, Dr. Chao’s vision and past achievements in generics to capture a significant share in this lucrative area. “Tanvex has historically focused on biosimilars, aligning with Dr. Chao’s vision to replicate his success in generics into the big biosimilars market,” Chen asserts.

Bearing this in mind, Tanvex aims to increase its visibility and appeal to a broader range of biopharma companies. They emphasize focusing on biotech firms with significant potential in biologics rather than targeting blockbuster drugs or first-tier pharmaceutical companies, acknowledging their current infrastructure’s limitations for large-scale commercial production. 

Their strategy is to engage with biotechs early in their development, supporting them through phases one to three of clinical trials, with a particular interest in promising programs that could advance to phase two. While their current capabilities may not fully support commercial-scale production, they highlight the potential for handling antibody-drug conjugates (ADCs) in the future. 

“ADCs are the exception, that’s our sweet spot. If we hit our sweet spot, we’ll continue to grow. If we continue to grow, we’ll hit commercial one day. But this is where I think it’s the right strategy for it!”

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Author

Bernice Lottering