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.
4. FDA to keep pace of fast approval of new drugs
FDA approved the marketing of 59 new drugs in total in 2018, which was well above the 10-year average of 33 per year. So many new drugs being approved for marketing in such a short period were mainly thanks to the "acceleration" policies of FDA: in 2018, 41% new drugs approved were marketed through Fast Track, and 73% new drugs received the Priority Review Designation (including such designation received through purchase).
Another characteristic of the new drugs approved in 2018 was the large number of orphan drugs: 34 orphan drugs for rare diseases were approved, accounting for 58%, which was inseparable from FDA’s favorable policy for orphan drugs. FDA’s four acceleration policies: Breakthrough Therapy, Priority Review, Fast Track, and Accelerated Approval, as well as Orphan Drug Designation significantly promote new drug development and approval.
In 2019, FDA will continue the pace of new drug approval of 2018, presuming the government shutdown ends soon. Affected by the shutdown, FDA is unable to accept new drug applications and relevant fees, but can only work on applications submitted at the end of 2018, which will undoubtedly affect the number of new drugs approved in 2019.
5. Rise of the chief digital officer
Pfizer appointed Lidia Fonseca as the company's first chief digital and technology officer in Jan. 2019, to take charge of creating a strategy that improves Pfizer’s "digital capabilities". Before this, Merck, GSK, Novartis, and Eli Lilly have added similar positions to their executive committees, showing that pharmaceutical enterprises and medical supply distribution companies are paying more attention to their digital infrastructure. Pharmaceutical enterprises expect to increase the new drug R&D efficiency and control the design and normal proceeding of complex clinical trials through the application of digital information technology (AI).
"In every area — from where we innovate and find new medicines to how we operate, how we think about manufacturing and supply chain to how our sales reps do their work every single day — we are working on major projects to scale our digital capabilities," said Novartis CEO Vas Narasimhan at the J.P. Morgan Healthcare Conference this year.
6. Biosimilars to begin to strike back in the U.S.
Biosimilars act like a duck to water in the EU, but are in a difficult situation in the U.S. due to differences of the U.S. and EU policies, however, such difficult situation of biosimilars may shift in the U.S.
FDA approved the marketing of 7 biosimilars in total in 2018, accounting for 43.8% of the total approved in history (7/16), showing FDA’s inclination to biosimilars. FDA commissioner Scott Gottlieb has recently mentioned in a tweet that there are about 70 biosimilars in development.
And the number of biosimilars launched to the market also increased. Biosimilars from Pfizer (Nivestym), Mylan (Fulphila), and Coherus BioSciences (Udenyca) were successively marketed in 2018, while there were only 3 (Zarxio, Infectra, and Renflexis) marketed in the three years from 2015 when FDA started to approve the marketing of biosimilars to 2017. Both the approval speed and marketing speed of biosimilars are increasing.
And the expiration of patent periods of some original drugs will give opportunities to corresponding biosimilars. The major patent protection of Roche’s oncology drug: Herceptin will expire this year and Pfizer already has one Herceptin biosimilar which will be reviewed in 2019. FDA also hopes more biosi...
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