Deerfield Beach, FL -- (SBWIRE) -- 07/14/2015 -- The global market for biosimilar drugs is due to come under attack from popular generic drugs, as governments fight to control rising healthcare expenditure, according to healthcare experts.

Biosimilars – Regulatory Framework and Pipeline Analysis

Biosimilars are copied versions of biologics that offer a 20-50% reduction in cost compared with innovative biologic products. Biosimilars are getting the world wide attention as the cost of the innovative biologics are enormously high and even minimal reduction in price will reduce the healthcare spending substantially. All the countries are focusing on reducing the healthcare expenditure and biosimilars compliments to this goal. Biologic products are complex in structure and follow a complex manufacturing process thus, some variation exists between the reference product and its biosimilar.

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It is very important to assess the variations in biosimilars by comparing with reference product to ensure quality, non-clinical, and clinical properties, which has given rise to the regulatory requirements for biosimilars. Regulatory requirement for approving biosimilars varies across different regulatory bodies. However, all the countries have derived the basic theme from EMA and WHO guidelines for framing their regulatory structure. There is a need to harmonize the nomenclature of biosimilars, extrapolation of indications, and interchangeability of biosimilars with reference products across the regulatory bodies. Biosimilars market is developing and it could be well established with the pipeline that is poised to deliver a wave of biosimilars in the market in the near future

However, the increasing awareness of biosimilars among physicians and patients could help biosimilars to gain significant market share, leading companies to consider offering reimbursements to patients for biosimilar products.

Clinical activities for biosimilars can take six to eight years — a time-consuming and costly process — and, while generic drug manufacturing can cost up to $5m, biosimilar development can cost as much as $80m–$120m. This is primarily due to the complex structure of biological drugs, which are difficult to manufacture, and the high number of patients required for trials to prove efficacy and safety.

The possibility of failure in the biosimilars development process is also significant, and even obtaining marketing authorization for biosimilars is an extensive and difficult process. As a result, only a small number of companies can afford to enter the biosimilars market.

The biosimilars market in emerging economies was valued at $0.3 billion in 2002 and grew to a value of $3.3 billion in 2010 at a Compound Annual Growth Rate (CAGR) of 34%. It is forecast to grow further at a CAGR of 12% from 2010 to 2018, reaching $8 billion by 2018 at a CAGR of 12%

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Scope

- The scope of the report includes:
- Introduction
- Market dynamics: Trends, Drivers, and Barriers
- WHO guidance for biosimilars

Regulatory overview, biosimilar guidelines, regulatory framework for biosimilars, and market outlook for:

- Europe
- USA
- India
- South Korea
- Japan
- China

Key players

- Pipeline Analysis
- Overview
- Stage of Development / Molecule / Therapy Area / Indication
- Late-Stage / Phase II / Phase I Pipeline Biosimilars

Reasons To Buy

- The report will enhance your decision-making capability by allowing you to:

- Understand the regulatory requirement and regulatory framework that facilitates effective product development strategy as biosimilars industry is currently highly focused, growing, and outpacing the growth rate of small molecule pharmaceutical market

- Targeting geographies would be easy by comparing different regulatory frameworks; this would also provide a base for designing a strategy to enter the developed markets. Biosimilars are of interest in developed countries to reduce the healthcare expenditure

- With the recent approvals of biosimilars by USFDA, the biosimilars market is going to grow and this report examines the post approval market landscape

- Examine the biosimilars pipeline and specifies the products that are highly targeted, it also includes analysis of highly focused indications, mechanism of actions, and therapy areas in the pipeline

- Analyze the details of the clinical pipeline that includes late stage products, Phase II, and Phase I products. Detailed understanding of the pipeline will help in targeting the products for development, rate the current products and predict the competition

- Patients can save around 30% through buying biosimilars rather than the corresponding innovator products, but this is still comparatively more expensive than generic drugs, which can offer up to a 90% saving. Given that a biologic treatment for metastatic cancer can cost as much as $200,000 per year, even a substantial reduction in the cost of treatment with biosimilars will not match the value of generics. Most patients in emerging economies pay for medicine-related costs out-of-pocket, and affordability is therefore an issue for biosimilar manufacturers.

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