The Biosimilars and Follow-on Biologics Market Report 2024-2034: This report will prove invaluable to leading firms striving for new revenue pockets if they wish to better understand the industry and its underlying dynamics. It will be useful for companies that would like to expand into different industries or to expand their existing operations in a new region.

Increasing Demand of Drugs For Treating Chronic Conditions

The increasing demand for drugs stems from their remarkable efficacy in treating a wide array of chronic and complex diseases, ranging from cancer to autoimmune disorders and beyond. Chronic conditions such as diabetes, rheumatoid arthritis, and various forms of cancer are becoming increasingly prevalent, driving up the need for effective long-term treatments. This surge is propelled by various factors, including the aging population, the prevalence of lifestyle-related ailments, and advancements in medical science enabling earlier detection and prolonged treatment.

As our understanding of disease mechanisms deepens, biologics...

The Biosimilars and Follow-On Biologics Market Report 2023-2033: This report will prove invaluable to leading firms striving for new revenue pockets if they wish to better understand the industry and its underlying dynamics. It will be useful for companies that would like to expand into different industries or to expand their existing operations in a new region.

Regulatory Hurdles Slowing Down Access to Biosimilars
Even in mature areas where regulations for standard generics have been in place for some time, there are still certain challenges, particularly with regard to sophisticated generics. Product categories like respiratory and some long-acting injectables, for instance, still require a large amount of evidence production, which drives up costs and restricts the availability of generics in these markets. This is frequently accompanied by intellectual property (IP) disputes and legal actions, wherein originators are granted prolonged protection periods beyond the initial time intended for the submitted innovation, delaying Gene...

Summary

Biosimilars are drugs that are highly similar but not identical to branded “innovator” biologics: large molecule, immunogenic drugs produced from living cells. “Innovator” biologics are the first to be approved, and when their patent protection expires, biosimilars may be approved, in a similar way to small molecule branded drugs and their generics.

There are no clinically meaningful differences in quality, safety and efficacy between biosimilars and innovator biologics. The exact definition of a biosimilar varies by regulator.

Biosimilars bring competition to expensive innovator biologics and represent a cost-saving option for payers.

More than 50 biosimilars are approved in the EU, while the FDA lags behind with 17 approvals but is catching up fast. As more innovator biologics come off-patent in the near future, this will bring a huge opportunity for biosimilar companies and for biosimilar manufacturers.

Key Questions Answered

- What biosimilars are marketed in the US and EU?
- How is biosimilar manufacturing an...

Summary

This Physician Perspectives survey focuses on the use of biosimilar anti-TNFs in IBD.

In the next 12 months, nearly half of physicians stated that they would consider switching Remicade patients (in remission) over to biosimilar IFX. A large proportion of physicians reported that their patients have at least occasionally expressed concern (rated >3) over being switched onto a biosimilar anti-TNF from an originator anti-TNF (67%) or being prescribed a biosimilar anti-TNF (54%). Overall, the majority of physicians agreed that they would require a biosimilar to be designated as interchangeable before considering switching patients from an originator to a biosimilar (67%).

The report includes following topics -
- Familiarity with biosimilar IFX
- Expected use of biosimilars - IFX & ADA
- Concerns with biosimilars
- Switching & Interchangeability.

Scope

- Sociable Pharma conducted an online survey in Q4 2017, with 100 specialist gastroenterologists
- Physicians interviewed were from 5EU and US countries › This r...

Summary

Recent trends in drug development have seen the price of new medicines continually increase, and there is a need for cheaper medicines to achieve global sustainable healthcare. Biologic drugs are some of the most expensive medicines to develop, as they are large complex molecules. Biosimilars are highly similar to approved biologic drugs, with no clinically relevant differences, and aim to achieve the same clinical results at a lower price than their originator molecules. This is a key way in which the cost-savings required to promote sustainability can be achieved.

In oncology, biosimilar versions of six biologic drugs are now available. The EMA has pioneered regulatory acceptance of biosimilars, and has approved many more biosimilars than the FDA. Beyond the major markets of the US and 5EU (France, Germany, Italy, Spain and UK), two emerging markets are important in the oncology biosimilars landscape: India, with the most approved biosimilars globally, and South Korea, home to major biosimilar developer Celltrion.

This report provides an asses...

Summary

GBI Research’s latest report, "Global Biosimilar Pipeline and Market Prospects: Addressing Production Complexities Through Risk Management and Quality by Design" provides an in-depth assessment of the current trends in the global biosimilars market, with a particular focus on manufacturing complexities and the strategies being implemented to overcome them. This report also assesses the state of the biosimilar R&D and commercial landscape through multilevel analytics that include data split by therapy area, stage of development, molecular target, clinical trials and company. Global revenue forecasts to 2022 for biosimilars with strong market potential, both in development and in the market, are provided.

The complex requirements of manufacturing biological drugs also apply to biosimilars, and these have been a significant barrier to the further expansion of the biosimilars market. A key challenge has been the knowledge gap under which biosimilars are developed, which arises from the fact that innovator product information remains proprietary...

Summary

The cancer supportive care product market consists of drugs intended to prevent or treat the symptoms of cancer, and reduce the side effects of cancer treatments. Instead of extending a patient’s life expectancy, the emphasis is on improving overall quality of life. The key indications covered in this report are cancer pain, oral mucositis, chemotherapy-induced neutropenia (CIN), chemotherapy-induced anemia (CIA), chemotherapy-induced nausea and vomiting (CINV) and bone metastasis. These indications are not only distressing for patients, but can also lead to treatment cessation, which in turn increases patient mortality. As the number of people being diagnosed with cancer grows and access to effective treatment that allows patients to survive longer increases, demand for safe and effective cancer supportive care drugs will rise.

The majority of indications targeted by cancer supportive care products are the direct result of a patient receiving chemotherapy in an attempt to cure their cancer or relieve symptoms. It is often the case that the most effe...