What are the emerging issues in pharmaceuticals in 2018?

What are the emerging issues in pharmaceuticals in 2018?

New Year, New Trends

The new year is likely to bring notable development in several areas of the pharma industry, according to Ned Pagliarulo, Lisa LaMotta and Jacob Bell, writing on the website www.biopharmadive.com.

One likely trend is lower wholesale and retail prices. President Donald Trump has spoken in favor of lower drug prices, and the new Secretary of Health and Human Services (HHS), Alex Azar, is on record as saying that reduced drug costs “would be a top priority.” Pharma industry lobbyists are trying to change the public focus onto alleged “middlemen” in the pharma commerce chain and away from the manufacturers. Some new drugs are already being priced lower than expected and lower than existing competition in anticipation of downward regulations on pricing.

Mergers and acquisitions are likely in 2018. With major tax reform now a fact, the process of larger drug companies absorbing smaller ones is likely to resume. Large volumes of cash that have been kept out of the country to avoid taxes can now be brought back and used for buying out the competition.

Gene therapy is emerging. This exciting new frontier in medical treatment is expected to grow in the new year. In 2017 the Food and Drug Administration (FDA) approved CAR-T cell therapy, in which white blood cells are genetically altered outside the body and then reintroduced to fight some cancers more effectively. Gene therapy for hemophilia may be next. As more breakthroughs occur, pricing will become an issue, especially for those therapies that target rare diseases and have small patient populations available to pay for the cost of development.

Biosimilars will be big. Also called “copycat drugs,” most are cancer treatments.  The FDA is encouraging production of these to increase competition. Copycat drugs may save up to $150 billion over the next decade, but producers of the originals are in some cases reaching financial settlements with copycat producers – paying them off – to delay introduction of the new drugs.

The opioid epidemic will continue to make news. Heavily covered by the media, opioid abuse has led to legislation and lawsuits from multiple states that claim that the pharma industry is encouraging addiction and overdosing through overly aggressive marketing. Starting with Massachusetts in 2016, 24 states now set limits on the length of initial prescriptions for opioids. The FDA is seeking the development of new, non-opioid analgesics, and a new generation of non-steroidal anti-inflammatories (NSAIs) is likely to appear. Zilretta has already gained approval for a n NSAI aimed at osteoarthritis, while Ampio Pharmaceuticals and Flexion Therapautics have NSAIs in the testing phase.

Ophthalmology drugs look attractive. These drugs are among the most profitable in the whole pharma industry, so new ones are likely to appear, especially in the treatment of dry eyes. Shire has developed Xiidra for this condition, received FDA approval and promptly bought another dry eye treatment, P-321, developed by Parion Science and now in testing. Novartis AG has recently bought another such drug, Lubricin, from Lubris Biopharma LLC.  More new medications are likely to appear in this growth area.

It will be interesting to see how these trends play out over the course of 2018.

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