Submitted: 27 August 2024; Revised: 23 October 2024; Accepted: 23 October 2024; Published online first: 7 November 2024

Introduction

Biosimilars have emerged as an important sector in medicine, improving global healthcare access in areas ranging from diabetes to cancer. They present one of the greatest opportunities to control drug costs, enhance patient care, and expand access to essential treatments.

CinnaGen, established in 1994, is the largest Iranian biopharmaceutical company and the biggest in the Middle East and North Africa (MENA) region. CinnaGen Group currently consists of eight companies that are active in different pharmaceutical areas including recombinant proteins, monoclonal antibodies, high-tech chemical drugs and niche dietary supplements, covering stages from early R & D to production, clinical studies, sales and marketing. CinnaGen Group entered the biosimilars field in 2006 when it manufactured its first follow-on biological (FOB)/biosimilar product in collaboration with the Fraunhofer Institute in Germany.

The company focuses its efforts on development of FOBs in the areas of immunological diseases, infertility, hormone disorders (endocrinology), haematology, neurology, oncology, ophthalmology and rare disease, in addition to providing contract research and development services.

In an interview on 27 August 2024, Dr Haleh Hamedifar, Chairperson of CinnaGen, discussed her views on FOBs and the company’s plans regarding them with GaBI (Generics and Biosimilars Initiative).

Clinical development programme for follow-on biologicals/biosimilars

A clinical development programme for biosimilars involves rigorous testing to demonstrate that a new biosimilar product is highly similar to an existing, approved biological in terms of safety, efficacy, and quality.

The company is actively engaged in clinical development for FOBs/biosimilars in the MENA region, India, Commonwealth of Independent States (CIS) region, and Europe. These efforts encompass several key drugs in the treatment areas of autoimmune diseases, blood disorder, and cancer, including efmoroctocog alfa, adalimumab, ocrelizumab, pembrolizumab, eptacog alfa, laronidase, see Table 1.

These clinical studies aim to demonstrate the safety and efficacy of the FOBs/biosimilars. Once approved, these products will offer patients more affordable treatment options. The focus of this clinical development programme is also on increasing the availability of FOBs/biosimilars in these regions, thereby improving patient access to essential therapies amidst economic challenges and the rising demand for biological treatments.

CinnaGen ensures the safety and efficacy of its FOBs/biosimilars by adhering to the European Medicines Agency (EMA) guidelines. The stepwise approach in developing the FOB/biosimilars includes analytical characterization to confirm similarity with the reference product, non-clinical studies to assess potential risks and side effects, clinical pharmacology studies to evaluate pharmacokinetics and pharmacodynamics, clinical trials to compare safety and efficacy, and post-marketing surveillance in real-world settings. Additionally, CinnaGen employs advanced technology in molecular biology, protein engineering, and process development to develop high-quality biosimilars.

Biopharmaceutical drug development and commercialization

Building on its clinical development success, CinnaGen has made significant progress in drug development, particularly for multiple sclerosis (MS) treatment. One of the company’s key achievements was the successful launch Xacrel, an FOB/biosimilar to Ocrevus (ocrelizumab), on 17 March 2021 in Iran. Xacrel is approved for various forms of MS, including relapsing-remitting disease, active secondary progressive disease, and primary progressive MS in adults.

The launch in Iran has been well received, with many MS patients switching to Xacrel, leading to an estimated exposure of 5,356 patients. To date, 43,320 vials of Xacrel have been sold in the MENA region, providing treatment for an estimated 7,220 patients. This success represents a more accessible treatment option for MS patients.

CinnaGen is actively seeking approval for Xacrel in other countries and expects to secure it within the next few years.

In a similar vein, CinnaGen achieved another milestone with the launch of its FOB for Aldurazyme (laronidase) on 13 February 2024, in Iran. This marks the first enzyme replacement therapy biosimilar developed in the MENA region. Laronidase is used to treat Mucopolysaccharidosis I (MPS I), targeting patients with Hurler and Hurler-Scheie forms of the disease, as well as those with the Scheie form who exhibit moderate to severe symptoms.

Long-term vision and a 10-year plan in the biopharma space

CinnaGen’s long-term vision focuses on expanding its global footprint and enhancing its product portfolio over the next five to 10 years. Central to this vision is entering highly regulated markets such as Australia, the European Union, and Japan, which will broaden the company’s patient base and increase its market presence. These markets offer substantial opportunities for growth, but navigating complex regulatory frameworks will require strategic partnerships and compliance with stringent standards.

Achieving this vision will involve substantial regulatory and strategic planning. Success in these markets demands a deep understanding of regional market dynamics, building relationships with regulatory authorities, and adhering to strict quality standards. CinnaGen plans to develop local capabilities, forge partnerships, and leverage its expertise in biopharmaceutical development and manufacturing to ensure compliance and maximize opportunities in these competitive regions.

In addition to geographical expansion, CinnaGen is committed to developing the next generation of biological products. By investing in cutting-edge research and advanced technology, the company aims to meet evolving patient needs and improve treatment outcomes. This commitment, combined with its strategic partnerships [1], will ensure CinnaGen’s sustained growth and leadership in the global biopharmaceutical landscape.

Follow-on biologicals/biosimilars in the MENA region: the case of adalimumab

In the MENA region, Iran has emerged as a leader in adopting FOB/biosimilar products, notably with the launch of CinnoRA, an adalimumab FOB, in September 2016. This launch has driven significant growth in the adalimumab market, with adoption rates exceeding initial expectations. It underscores the potential of biosimilars to enhance patient care and expand access to essential treatments in the region.

CinnoRA has had a considerable impact on the market since its launch, with sales figures demonstrating that the product has exceeded initial expectations, with an estimated 79,711 patients to have used CinnoRA since its launch.

Competitive advantage

At CinnaGen, the distinct combination of strengths distinguishes the company within the biosimilar industry. Key competitive advantages include:

• Large-Scale Manufacturing Capacity: With over 50,000 liters of bioreactor capacity in commercial operation, the company’s production scale ranks among one of the largest globally. This enables the company to deliver products more competitively.
• Intellectual Property Flexibility: Since Iran is not part of the World Trade Organization, the company can develop and market its products faster than competitors. For international partnerships or joint ventures, potential partners benefit from access to real-world data and de-risked, commercialized assets, enhancing investment confidence.
• Sophisticated Product Portfolio: With over 19 FOB/biosimilars on the market, see Table 1, and more than 25 in development, CinnaGen boasts one of the most comprehensive FOB/biosimilar portfolios in the MENA and CIS regions [2], covering therapeutic areas like endocrinology, haematology, immunology, neurology, ophthalmology, oncology, and rare diseases.

Current FOB/biosimilar products development of CinnaGen

The company has launched over 19 FOB/biosimilar products in the MENA region [2], see Table 1, and secure good manufacturing practices (GMP) certification from stringent regulatory authorities such as the EMA in 2018 [3].

Furthermore, AryoGen, a member company of CinnaGen, produced a range of FOBs notably bevacizumab (Stivant), rituximab (Zytux), trastuzumab (AryoTrust), etanercept (Altebrel), see Table 2, which are available in the MENA region.

Conclusion

CinnaGen’s strategic focus on innovation, expansion of its FOB/biosimilar portfolio, and entry into highly regulated global markets positions the company as a key player in the biopharmaceutical landscape. Its commitment to affordable, accessible health care through the development of high-quality biosimilars is transforming patient care, particularly in underserved regions like MENA. Coupled with its strong corporate responsibility initiatives, the company’s long-term vision ensures that CinnaGen is not only shaping the future of biopharmaceutical manufacturing in the MENA region but also contributing to sustainable healthcare solutions worldwide. As CinnaGen continues to grow, its leadership in biosimilar development is set to create lasting, positive impacts on global health.

Competing interests: This article was funded by CinnaGen.

Provenance and peer review: Article prepared based on the interview conducted on 27 August 2024; internally peer reviewed.

References
1. GaBI Online – Generics and Biosimilars Initiative. CinnaGen to invest in Turkish pharmaceuticals sector [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 23]. Available from: www.gabionline.net/pharma-news/CinnaGen-to-invest-in-Turkish-pharmaceuticals-sector
2. CinnaGen [homepage on the Internet]. [cited 2024 Oct 23]. Available from: https://www.cinnagen.com/
3. GaBI Online – Generics and Biosimilars Initiative. MENA region biologicals maker CinnaGen receives Eu GMP certification [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 23]. Available from: www.gabionline.net/pharma-news/MENA-region-biologicals-maker-CinnaGen-receives-EU-GMP-certification

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