Seven Trends of the Pharmaceutical Industry in 2019 (2)

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 biosimilars that can replace original drugs to enter the market, so as to save the medical expenses. According to data, discounts for original drugs begin to climb as more biosimilars enter.

7. Cell and gene therapies to grow

FDA approved the marketing of two cell therapies (Kymriah, Yescarta) and the first gene therapy Luxturna in 2017; and it approved the marketing of two RNA therapies (Onpattro, Tegsedi) in 2018. If the 20^th century is a turning point of monoclonal antibodies, then the 21^st century will be a turning point of cell and gene therapies.

FDA commissioner Scott Gottlieb and CBER director Peter Marks jointly released an announcement on Jan. 16, 2019 to introduce FDA’s new initiatives for promoting cell and gene therapy development. The announcement mentioned that FDA has accumulatively received more than 800 IND applications on cell or gene therapy. According to the forecast of Scott Gottlieb, over 200 relevant IND applications will be received every year by 2020; and 10-20 cell or gene therapy products will be approved by FDA every year by 2025.

Advancement of science and technology relating to cell or gene therapy plays a major role therein. Delivery platforms like adeno-associated viruses help enable the replacement of defective genes, while technologies such as CRISPR/cas9 hold the promise of direct genetic editing. Those innovative therapies will lead to the surge of cell or gene therapy products.

According to the new initiatives launched by FDA recently, FDA will cooperate with gene or cell therapy development companies, and review gene or cell therapies through acceleration channels; FDA will also issue a series of clinical guidance documents for gene or cell therapies, and guidance documents for the production and use of CAR T-cell therapies. All the above will promote the R&D of gene or cell therapies.

Read More:

Seven Trends of the Pharmaceutical Industry in 2019 (1)

References:

Congressional investigation targets Pfizer, Novartis and J&J, among others

7 biopharma trends to watch in 2019

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