FDA reached a record high in 2018 by approving the marketing of 59 new drugs in total. Then, what will be the trends of the medical world in 2019? BMS’ major acquisition of Celgene makes oncology therapies become the focus again, drug price increase adds keywords such as government pressure, drug price, and biosimilar to 2019, and more innovative therapies are expected to be approved as FDA commissioner Scott Gottlieb has an interest in promoting cell therapy and gene therapy development.

Government departments to increase investigation on pharmaceutical enterprises

Elijah Cummings, the new Chairman of the U.S. House Oversight Committee, requested price information and documents of 18 marketed drugs from 12 pharmaceutical enterprises on Jan. 14, 2019, which had the largest increases in 5 years, involving Pfizer, Novartis, Johnson & Johnson, and AbbVie, etc. Among Cummings' first acts as the Chairman was announcement of the pharmaceutical enterprises and drug prices as his major regulation targets.

Drugs Required by Cummings to be Provided with the Pricing Details

(Source: Reference 1)

The U.S. Congress has periodically put the pharmaceutical enterprises’ pricing practices at the center of its scrutiny in years past. Pharmaceutical enterprises have been under bigger pressure since Trump took office as the U.S. President. Trump has successively criticized price rise of pharmaceutical enterprises as "immoral" in his tweets in 2018 and 2019. After the price increase of nearly 100 drugs in Jan. 2019, the Trump administration has introduced 3 relevant bills, and said that Democrats and Republicans would cooperate to reduce the drug prices.

Cummings will chair a hearing on drug prices on Jan. 29, 2019, which will discuss the pricing details of the above 18 drugs and invite relevant experts and patients. What is uncertain now is whether CEOs of pharmaceutical enterprises will be present and answer relevant questions, but what can be certain is that pharmaceutical enterprises will face bigger pressure from the government in 2019.

Drug price hikes to remain, but companies become more selective

Continue the above drug price topic. As forecast by Pfizer in 2018, pharmaceutical enterprises and medical supply distribution companies have increased prices of dozens of major drugs in Jan. 2019 as usual. According to the investor Raymond James after conducting statistics of drugs increased prices in last two months, pharmaceutical enterprises are becoming more selective in which drugs they take increases on, compared to previous years.

Merck, for example, in Nov. 2018 increased the prices of its top-selling cancer drug Keytruda and its vaccine Gardasil, i.e., its most promising drugs in the future, and Eli Lilly, Biogen, and Pfizer did it the same way. Such an approach could appropriately ease their tension with the government, while obtaining higher sales through price increase.

Oncology therapies to become a center of pharmaceutical enterprises

In recent years, pharmaceutical enterprises have gradually prioritized investment into cancer drug development, instead of laying out R&D pipelines in many disease areas. GSK’s acquisition of Tesaro in Dec. 2018, BMS’ acquisition of Celgene and Eli Lilly’s acquisition of Loxo in Jan. 2019 are clear signals that large pharmaceutical enterprises are strengthening their oncology R&D pipelines, to preoccupy this hot market.

Cancer drug R&D is also catalyzed by the progress of science and technology and clinical studies. FDA approved a total 17 oncology drugs in 2018, accounting for 28.8% of the total (17/59), and the first RNA therapy was launched. Pharmaceutical enterprises remain eager to invest in oncology drug R&D, even as competition increases and pipelines swell. Pharmaceutical enterprises like AstraZeneca, Gilead, and Regeneron have successively paid more attention to their oncology drug R&D.

Read More:

Seven Trends of the Pharmaceutical Industry in 2019 (2)

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