A biosimilar is a biological product that closely mimics and is identical to a previously approved reference product. These are less expensive than branded or authorized items. Several cancer biologics have already lost their patents, and others are about to expire. Biosimilars are likely to gain popularity as more products lose their patents. Leading generics companies including Mylan N.V., Teva Pharmaceutical Industries Ltd., Allergan Plc., and Sandoz are likely to benefit from these patent expirations and position themselves as market leaders in cancer biosimilars.
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During the forecast period, quick clearance of biosimilars for oncology is projected to be a significant catalyst for the global oncology biosimilars market to expand.
The authorization of the first biosimilars in two important markets, Europe and the U.S., took nearly a decade. In Europe, the first biosimilar was authorized in 2006; while, in the U.S., the first product was approved in 2015. The FDA, on the other hand, has authorized five biosimilars since the first was authorized in 2017. Two of the five biosimilars have been authorized for use in cancer treatment. Mvasi, a cancer biosimilar, was authorized in September 2017, and Ogivri, an oncology spinoff, was approved in December 2017. Both medicines have been authorized in Europe, with Mvasi receiving clearance from the European Commission in January 2018.
In the U.S., a variety of biosimilar applications are underway. There are now four applications pending with the FDA for Herceptin alone. Amgen and Allergan, Celltrion and Teva, Pfizer, and Samsung Bioepis are the companies behind these four applications. Recent product approvals, as well as prospective approvals in the coming years, are projected to drive market expansion throughout the forecast period.
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During the forecast period, North America is projected to lead the global oncology biosimilars market. During the forecast period, North America is anticipated to be the most important market. The first biosimilar was authorized by the FDA in the U.S. in 2015, over a decade after the first biosimilar was approved in Europe. The number of authorized goods has dramatically grown since 2015. This is projected to be a factor in the market’s expansion in North America. Furthermore, there are a number of products in the pipeline that might be approved by the FDA throughout the forecast period. Pfizer Inc., a U.S.-based business, has three biosimilar oncology medicines in Phase III.
During the forecast period, the European market is similarly projected to develop rapidly. Key goods are anticipated to be launched in the market over the forecast period. Major generic manufacturers in Europe, such as Sandoz and Mylan N.V., have expressed interest in this sector. In 2009, Mylan N.V. and Biocon Limited signed a cooperation agreement to develop biosimilars. In 2017, the pair received FDA clearance for their first biosimilar drug, and in the same year, the European Medicines Agency (EMA) accepted a revision for their Herceptin biosimilar. The global oncology biosimilars market in the territory is anticipated to develop significantly over the forecast period, owing to an increase in the number of authorized medicines.
Major companies contributing in the global oncology biosimilars market are Teva Pharmaceutical Industries Ltd., Celltrion Healthcare, Mylan N.V., Allergan, Plc, Amgen Inc., Biocon Limited, Biogen Idec, Inc., Samsung Bioepis Co., Ltd., Novartis International AG, and Pfizer Inc.
Oncology Biosimilars Market Taxonomy
By Cancer Type:
- Lung Cancer
- Colorectal cancer
- Cervical Cancer
- Breast Cancer
- Kidney cancer
- Stomach cancer
- Brain Cancer
By Product Type:
- Monoclonal Antibody
By Distribution Channel:
- Hospital Pharmacies
- Online Pharmacies
- Retail Pharmacies
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Current and future of global Oncology Biosimilars market outlook in the developed and emerging markets
The segment that is expected to dominate the market as well as the segment which holds highest CAGR in the forecast period.
Regions/countries that are expected to witness the fastest growth rates during the forecast period
The latest developments, market shares, and strategies that are employed by the major market players
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Table of Content
Global Oncology Biosimilars Market Research Report
Section 1: Global Oncology Biosimilars Industry Overview
Section 2: Global Economic Impact on Oncology Biosimilars Industry
Section 3: Global Market Competition by Industry Producers
Section 4: Global Productions, Revenue (Value), according to Regions
Section 5: Global Supplies (Production), Consumption, Export, Import, geographically
Section 6: Global Productions, Revenue (Value), Price Trend, Product Type
Section 7: Global Market Analysis, on the basis of Application
Section 8: Oncology Biosimilars Market Pricing Analysis
Section 9: Market Chain, Sourcing Strategy, and Downstream Buyers
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