There are variations in regulatory consideration for biosimilars products around the world which impacts globally. As, in Canada does not support automatic substitution. The UK and Belgium recommend prescribing by brand name so as to avoid substitutions. Spain and Germany prohibit automatic substitution. In Ireland, Poland and Portugal have no clear position. In Japan substitutions should be avoided during the pharmacovigilance study period. Hence, as the global market of biosimilars expand and biosimilars become more complex, it is very essential to ensure clarity in prescribing regulations and make uniform regulations for global practice to get a therapeutically important biosimilars. There is no single uniform international guideline for biosimilars. Rather, there is a contrast of a highly regulated and a less regulated registration pathway.

Highly regulated approval pathways:

• European Medicine Agency (EMA) - The announcement of the initial “guidelines on similar biological medicines” in 2005, the EMA has continued to be at the forefront of legislation governing biosimilars and a standard for regulatory authorities in other countries.
• US Food and Drug Administration (FDA) - In 2009, the US congress released the Biologic Price Competition and Innovation Act (BPCIA) as part of Patient Protection and Affordable Care Act, which empowered the FDA to identify an abbreviated approval pathway for biosimilars.

Less regulated regulatory pathways: In some countries, approval criteria for copies of original biologics are less stringent, to accelerate their potential for cost savings. The less rigorous comparative assessments in these countries have seen them referred to as a biopharmaceutical not subjected to regulatory approval. However, the guidelines for them are relatively vague.

• China: State Food and drug Administration (SFDA) regulates the biosimilars law, states that a biosimilars product must be registered and approved as new biological products.

In the type of manufacturing segment in-house manufacturing dominated the market in 2018, however contract manufacturing is set to grow at a highest CAGR. Patent expiries, lower R&D productivity, cost and time pressure have driven the CRO market till now. Over the years of relationship between sponsors and service providers has also changed. CROs have moved from being a service provider to being a preferred vendor and now acting as strategic partners with innovative companies across the globe.

Total biologic production capacity worldwide was estimated at approximately 2800m in 2010, 2000m of it was meant for captive use. This is expected to be augmented to approximately 3900m³ in 2017. Industry saw some consolidation of assets/ fresh capacity creation with Boehringer Ingelheim purchasing Amgen’s Fremont (CA) Biomanufacturing facility in 2011, Fujifilm acquiring Merck & Co’s contract manufacturing business in February 2011 and Samsung announcing plans to create manufacturing capacity of 120m, by 2017.

South Korea has taken the lead in active biologics, biosimilars and CRO manufacturing whereas contract biomanufacturing in India, China and Brazil is yet to reach scale. Multiple factors are driving the outsourcing of Biomanufacturing. Biosimilars API demand is expected to grow aggressively as biological drugs expiry will continue and more biosimilar products go for late stage clinical trials. Organizations trying to reduce their fixed costs and reduce their time to market will continue to outsource.

In 2018, Europe was the largest market for biosimilars and is anticipated to retain its position by 2025. However, Asia Pacific is expected to show promising growth in the forecast period.

Europe and the EU have historically been pioneers with regards to the regulatory approval and use of biosimilars – being the first to develop a biosimilar pathway in 2003 and the first to approve a biosimilar for marketing in 2006 and is now reaping the economic benefits, with increased availability of biological treatments at lower prices. At the same time, Europe maintains its lead role in fostering innovation, with more than 12,000 clinical trials on biologic medicines conducted in Europe to date, and a steady growth of biologic clinical trials activity. With increased patient access and healthcare system efficiencies generated through competition on the one hand and continued innovation on the other, the biosimilars represents a rapidly-growing segment of the European biopharmaceutical market, whose health, social and economic impact on the European economy is significant. Securing a sustainable future for the European biologics and biosimilars market is a top priority for European countries and for the European economy as a whole. 8 Driven by increasing demand for healthcare and its associated costs, many European countries are increasingly focusing on maximizing short-term savings rather than ensuring the long-term sustainability of this market. The lack of a unified approach and the high diversity of policies governing the daily practice of off-patent biologics may eventually undermine the goal of creating a sustainable European market for off-patent biologics.