With April quickly approaching, we are full steam ahead into the new year and all it has to offer. The Pharmaceutical industry is in a period of change, having to adapt to keep up with new healthcare initiatives in an effort to increase patient access. The industry has seen many recent trends that can be linked back to the FDA’s push to make access to medicine more affordable. Let’s take a look at several notable changes that will shape the landscape for the upcoming year:

FDA Making Changes to Improve Patient Access

“No patient should be priced out of the medicines they need, and as an agency dedicated to promoting public health, we must do our part to help patients get access to the treatments they require,” said FDA Commissioner Scott Gottlieb, M.D.

The FDA is taking steps to increase competition within the industry to result in lower cost treatment options for patients. The first action taken by the agency was publishing a list of off-patent drugs without approved generics. This list provides a two-fold opportunity for companies and patients: companies are encouraged to focus on getting these generics to market and in turn, patients have access to lower cost alternatives. To support this initiative the FDA also announced a change to policies, which will expedite the review of generic drug applications in effort to make affordable healthcare a reality sooner rather than later.

Record Breaking FDA Approvals in 2018

The FDA approved an all time high number of drugs in 2018. To support the efforts towards improving patient access they approved a total of 780 generic drugs during the 2018 fiscal year. During the same year they approved 59 novel drugs and biologics and this number surpassed the past record of 53 approvals in 1996. Of those 59 approvals, 25 were Orphan drugs and 7 were Biosimilars indicating the shift in funding towards rare disease in an effort to offer more treatment options to patients than ever before.

Biosimilars

On trend with the push for drugs to be more accessible and affordable for patients, we continue to see an increase in Biosimilars. They made up 12% of the new approvals last year and the market as a whole is anticipated to reach $11 Billion by 2022. Biosimilars are complex molecules composed of living material in an effort to be highly similar to their branded counterpart as opposed to chemically identical as a generic drug would be, resulting in quicker development. With the rapid growth of the Biosimilar market, we are seeing an increase in new jobs created to meet the demand and to market the products to the masses.

Focus on Rare Disease

While Biosimilars made up a decent percent of FDA approvals in 2018, Orphan drugs dominated the group with 34 approved drugs. The development of drugs that treat rare diseases can be very commercially beneficial for a Pharmaceutical company’s long term growth because the current FDA Orphan Drug Designation grants seven-year exclusivity rights for manufacturing. Many companies have seen this opportunity and shifted focus of their pipeline in this direction.

Collaboration over Competition

We have continued to see the trend of Pharmaceutical companies collaborating and entering strategic partnerships to bring new products to market. Embracing collaboration over competition is a way of working to overcome the challenges the industry is currently facing. This helps bring innovative products to market as soon as possible. With rising costs of R&D and the complexity of marketing new products, collaboration is the best option for companies to pool their resources and be successful.

We would be happy to discuss any of these trends with you and any of your company needs in the new year. Please contact: info@pharmaout.com

For more information about current trends in the pharmaceutical industry please visit:
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm564725.htm
https://www.the-scientist.com/features/how-orphan-drugs-became-a-highly-profitable-industry-64278
http://www.pmlive.com/pharma_news/orphan_drugs_dominate_fdas_record-breaking_year_1273631
https://www.examinebiosimilars.com/biosimilars-vs-generics.html
https://www.fiercebiotech.com/biotech/chugai-preps-filings-for-il-6-drug-rare-disease-chasing-soliris

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