Commercialization Of Biosimilars Research Articles

Regulatory requirements for biosimilars as per CDSCO in India in comparison with Yemen

This study examines the regulatory requirements for biosimilars in India and Yemen, highlighting similarities and differences between the Central Drugs Standard Control Organization (CDSCO) and the Ministry of Public Health and Population (MOPHP). The regulatory landscape for biosimilars is evolving globally, with varying requirements across countries. This comparative analysis examines the regulatory requirements for biosimilars in India, governed by the Central Drugs Standard Control Organization (CDSCO), and Yemen. A comprehensive review of guidelines, regulations, and approval processes reveals both similarities and differences between the two countries. While both CDSCO and Yemen require a comparability exercise to demonstrate bio similarity, differences exist in the regulatory framework, clinical trial requirements, and approval processes. CDSCO has a separate regulatory framework and abbreviated pathway for biosimilars, whereas Yemen adopts the MOPHP guidelines and has a registration process. This analysis highlights the need for manufacturers to understand the nuances of each market's regulatory requirements to ensure successful approval and commercialization of biosimilars. The findings of this study can inform regulatory agencies, industry stakeholders, and researchers working in the field of biosimilars.

Biosimilars in Pediatric IBD: Updated Considerations for Disease Management.

Biologic drugs have significantly modified the pharmacological management of several chronic conditions, including inflammatory bowel diseases (IBD). By contrast, in the last two decades, biologics have been associated with increased direct medical costs. As patents for the reference drugs have expired, the development and commercialization of biosimilars through abbreviated licensing pathways represented an affordable alternative in patients fulfilling the indication for biologics. A growing body of evidence, first in adults and then in the pediatric age group too, has provided reassuring data in terms of efficacy and safety of biosimilars both in naïve patients and in those previously on reference drugs who had to switch to the biosimilar. This review summarizes the currently available evidence for biosimilar use in IBD, with a focus on pediatric IBD. The most common practical approaches to biosimilar use in the pediatric clinical settings are also discussed.

Prospects and Challenges for the Commercialization of Biosimilars: Perspectives from the EU, Japan, and the US

With many blockbuster biologic drugs coming off patent in the next couple of years, biosimilars are making significant breakthroughs in cost-effective biologic therapies. The global market for biosimilars is expected to increase nearly 30 fold from $1.3 billion in 2013 to $35 billion by 2020. To promote biosimilar development and commercialization in the U.S., the Biosimilars Act was signed into law in 2010 to establish an abbreviated pathway by which the FDA could approve biosimilar versions of previously licensed biological products. Since its enactment, two biosimilars have been approved in the U.S. This Article will discuss key aspects of the U.S., the EU and Japanese approval pathways and will explore their likely impact on the commercialization of biosimilar medicines. Â

Biosimilars in India

Biosimilars have been defined as biotech drugs that have been shown to have comparable quality, safety and efficacy to the original product. The past decade has seen a significant increase in interest in these products from the biotech industry. Major developments have occurred with respect to establishing a regulatory path for approval of these products as well as in our understanding of how the different quality attributes of a biosimilar impact its safety and efficacy. India is globally regarded to have great potential to become a significant player in development and commercialization of biosimilars. This short communication aims to provide a brief discussion on where India is with respect to development and commercialization of biosimilars, major challenges it faces, and finally the significant role that proteomics can play in establishing analytical comparability of biosimilars.This article is part of a Special Issue entitled: Proteomics in India.

Biosimilars collaboration at Amgen and Actavis

Representatives from Amgen and Actavis have spoken to GaBI (Generics and Biosimilars Initiative) about biosimilars. Topics covered included the clinical development of biosimilars, the need for further education, how the partnership model between the companies was working, the commercialization of biosimilars

SAT0094 Relationship between the Duration of Rheumatology Practice Experience and Likelihood of Use and Perception towards Biosimilars in Rheumatoid Arthritis Arena

BackgroundRegulations surrounding clinical trials, manufacturing and commercialization of biosimilars is evolving. Potential barriers to biosimilar adoption in the real-world warrant scrutiny to enable patient access to these medicines.ObjectivesTo assess the...

Biosimilar Safety Considerations in Clinical Practice

Biologics are important treatments for a number of cancers. Patents for several biologics will expire over the next decade, removing a barrier to the development and commercialization of biosimilars. As biologics differ from small-molecule drugs due to their size and complexity, multifaceted manufacturing process, and their potential for immunogenicity, biosimilars cannot be considered "generic versions" of currently approved biologics. In highly regulated markets, biosimilars can be authorized only if they are demonstrated to be highly similar to the original drug from an analytical and clinical perspective. Any differences must be justified and shown to have no clinically meaningful effect on the safety and efficacy of the biosimilar. The European Medicines Agency has approved a number of biosimilars and the recent approval of the biosimilar infliximab monoclonal antibody is another regulatory milestone. This article will provide context regarding key safety issues addressed in biosimilar development, approval, and delivery, as well as inform oncologists on matters of safety to consider when prescribing biosimilars. Pertinent issues about safety from countries or regions where biosimilars are currently in use also will be reviewed.

Business of Biosimilars - 14th Annual Conference (October 15-17, 2013 - Boston, Massachusetts, USA)

Competition in the biological market offers a new set of opportunities and challenges within the healthcare industry. Biosimilars, like generic small-molecule drugs, can provide cost savings and increase patient access, while also promoting innovation. While large molecule manufacturers face many challenges unique to complex therapeutics, it is becoming clear that the commercialization of biosimilars shares many of the same hurdles as the generics market. The 14th Annual Business of Biosimilars Conference provided quality presentations from industry leaders regarding many commercial considerations for stakeholders interested in entering the biosimilars market. Opportunities to network with industry experts were offered, with over 120 attendees.

The State of the Art in the Development of Biosimilars

The development of biologic therapeutics using advanced technology to copy and improve on nature's design of complex peptides, proteins, and glycoproteins has enabled the treatment of diseases in entirely new ways and brought unique and lifesaving treatments to many people. However, at least in part because of cost pressures, access to these truly amazing products has not been uniformly available; many patients do not qualify for these treatments, or the treatment is postponed until disabilities accumulate. The development of biosimilars--essentially copies of the original biologic drugs after patent expiration--allows for wider and, as important, earlier access to these agents because of their lower cost and consequently greater affordability. The development and commercialization of biosimilars can help address unmet medical needs by improving access to well-established therapeutic interventions while improving health-care affordability.