The Rise of Biosimilars and Genetics

According to the FDA, biosimilars are highly similar to existing reference products approved by the FDA, and there are no significant clinical differences. In other words, biosimilars may not necessarily contain the same active ingredients as the reference product. On the contrary, generic drugs do contain the same active ingredients as branded drugs. Biosimilars and generic drugs are usually cheaper than branded drugs, but their respective regulatory methods are different.

According to the FDA, biosimilars are highly similar to existing FDA-approved reference products and do not have any meaningful clinical differences. In other words, biosimilars do not necessarily contain the same active ingredients as the reference product. Instead, generic drugs do contain the same active ingredients as trademark drugs. Biosimilars and generic drugs are generally cheaper than brand-name drugs, but they are regulated differently.
	As decades-old patents begin to expire, the industry has seen growth in biosimilars and generics. However, according to PwC, pharmaceutical companies will not focus on developing new patented products in the coming years. The drug markets in Brazil, Russia, India and China are all expected to spend about twice as much on generic drugs compared to patented products.
Part of this growth is due to the growing demand for cheap drugs. Generic versions of Lyrica, Advair and EpiPen all hit shelves this year, lowering prices for patients with neuralgia, asthma and life-threatening allergic reactions, respectively. After years of advocacy, the FDA released a new analysis showing that greater competition among generic drug manufacturers correlates with lower generic drug prices.

PwC expects countries with fast-growing economies, such as Brazil, Russia, India and China, to dominate the local generic market by 2020.

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