Bioequivalence Breakthroughs: Navigating the Landscape of Biosimilars in Modern Medicine


Bioequivalence Breakthroughs: Navigating the Landscape of Biosimilars in Modern Medicine

Biosimilars are complex biological products that are highly similar to an existing approved reference biologic, but they are not identical due to the inherent complexities of manufacturing large, intricate molecules derived from living organisms. Biosimilars structure is complex, including primary, secondary, tertiary, and quaternary structures. Achieving identical copies is challenging due to the variability in the manufacturing process. Biosimilars undergo extensive analytical studies to establish similarity in physicochemical properties, efficacy, and safety between the biosimilar and the reference biologic. Clinical trials are conducted to assess the biosimilar’s safety, efficacy, and immunogenicity compared to the reference biologic.

Many biosimilars are approved by the FDA, EMA, or other regulatory bodies for multiple treatments. In 2009, WHO (World Health Organisation) published its Guidelines for the evaluation of similar biotherapeutic products (SBPs) for effective evaluation of biosimilars under international norms. Some biosimilars may seek designation as interchangeable, indicating that they can be substituted for the reference product without the intervention of the healthcare provider.

Some of the challenges faced by biosimilars:

  1. Immunogenicity:
    • Biosimilars may elicit immune responses in some patients, and managing immunogenicity is a critical consideration in their development.
  2. Regulatory Complexity:
    • The regulatory pathway for biosimilars is complex and varies by region, requiring manufacturers to navigate stringent requirements.

Examples of Biosimilars:

1.       Adalimumab Biosimilars:

·         Biosimilar versions of adalimumab, a widely used anti-TNFα monoclonal antibody, have been developed and approved, including Amgevita, Hadlima, and Cyltezo.

2.       Rituximab Biosimilars:

·         Rituximab biosimilars, such as Truxima and Ruxience, have been developed as alternatives to the reference biologic Rituxan.

3.       Bevacizumab Biosimilars:

·         Bevacizumab biosimilars such as Mvasi (bevacizumab-awwb), Zirabev (bevacizumab-bvzr), Alymsys (bevacizumab-maly), and Vegzelma (bevacizumab-adcd) have been developed as alternatives to the reference biologic Avastin. December 19, 2023 FDA approved the fifth bevacizumab biosimilar, Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn) for the treatment of several types of cancer. 

Roche – Biogen Rivalry on Actemra Biosimilar’s

Actemra was approved by the FDA for the treatment of rheumatoid arthritis and also approved for the treatment of hospitalized patients with COVID-19. On July 13th, 2023, Chugai, Roche, and Genentech announced that they had filed a patent infringement lawsuit in the United States District Court for the District of Massachusetts on the grounds of Biogen’s abbreviated biologics license application (“aBLA”) to the FDA for approval of an Actemra® biosimilar (generic name: tocilizumab).

Seeking judgments based on BPCIA, a patent infringement lawsuit was filed against Biogen and its business partner Bio-Thera Solutions, Ltd., who developed biosimilar products subject to Biogen’s aBLA by Chugai, Roche, and Genentech’s U.S patents. Patents involved in the suit are not only limited to methods of using of tocilizumab in intravenous form and manufacturing methods of tocilizumab.

In April 2021, a commercialization and license agreement between Biogen and Bio-Thera Solutions together marketed Actemra biosimilar and reported that the Biogen sales in 2022 earned more than CHF 2.7 billion across the world. Also, it was observed that Actemra sales go decrease by 22% due to decreased demand for the drug as a COVID-19 treatment.

In September 2023, the FDA cleared abbreviated Biologics License Application (aBLA) for Biogen’s BIIB800 (Tofidence), making it the first approved biosimilar to Actemra.


Roche and Biogen

Roche had filed a lawsuit on the biosimilar would infringe many patents related to the manufacture and use of its biologic drug. Biogen and Bio-Thera did not respond to the allegations in court.

Finally, in October 2023, Roche settled a patent lawsuit against Biogen over its biosimilar version of Roche’s rheumatoid arthritis drug Actemra. Roche and its subsidiaries Genentech and Chugai Pharmaceutical jointly told the court that they had settled the case. Representatives of both companies failed to provide a statement concerning this drug. Roche in turn stated the importance of biosimilar competition in ensuring the financial sustainability of health care systems and encouraging for biologics market.

On the note of conclusion, the biosimilar or biologics market improved by developing new alternatives to the original drug which are at affordable prices. Biosimilar navigate modern medicine by promoting cost-effectiveness, expanding treatment options, improving patient access, adhering to rigorous regulatory standards, influencing market dynamics, facilitating global market expansion, and bridging treatment gaps.

These factors collectively contribute to the integration of biosimilar into mainstream medical practice, making them a key component of modern healthcare.

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