Biocad has announced that, on June 20, India’s Central Drugs Standard Control Organization (CDSCO) recommended its rituximab biosimilar (Acellbia) for approval. The company expects to receive a permanent marketing authorization for the product in August, and anticipates that it will begin shipping the treatment to India by September.
Biocad has announced that, on June 20, India’s Central Drugs Standard Control Organization (CDSCO) recommended its rituximab biosimilar (Acellbia) for approval. The company expects to receive a permanent marketing authorization for the product in August, and anticipates that it will begin shipping the treatment to India by September.
According to Biocad, the Indian market for rituximab exceeds $40 million annually, and total sales for rituximab products could reach $58 million over the next 5 years. The company states that, despite these impressive earnings, India has faced low availability of rituximab, and that it believes that its biosimilar’s market entry will not only spur price competition, but also result in greater patient access.
In June, the company’s rituximab biosimilar was also approved for marketing in Bolivia and Honduras, where it will be marketed under the name USMAL. The treatment is also available in 7 other countries worldwide, including Kazakhstan, Vietnam, and Sri Lanka. Biocad reports that it seeks to gain additional marketing authorizations for the drug within the year.
Dmitry Morozov, CEO of Biocad, says, “We are happy to see Acellbia, our first biosimilar drug product...receive [marketing authorization] in India, but our efforts to register more products there will continue.” The Saint Petersburg-based biotechnology company hopes to bring its second biosimilar to the Indian marketplace in the first quarter of 2018; Biocad expects to receive a marketing authorization for its trastuzumab biosimilar (Herticad), which is already supplied to countries including Syria and Sri Lanka, early next year.
Biocad’s trastuzumab biosimilar, referenced on Herceptin, was developed under a government funding initiative together with the company’s rituximab and bevacizumab biosimilars, and was first approved for marketing in Russia in 2016. At the time, the company expressed a hope that its biosimilar products would help make Russian healthcare less dependent upon foreign imports of biologic treatments. However, the company’s latest initiatives, including a substantial investment in Finland to supply drugs to the European marketplace, suggest that the booming company is not only poised to supply Russia with cost-saving biosimilar products, but also well on its way to creating competition within the global biologics market.
BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?
November 4th 2024The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.
BioRationality: Should mRNA Copies Be Filed as NDAs or Biosimilars?
November 4th 2024The article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products could be reconsidered, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.
2 Commerce Drive
Cranbury, NJ 08512