Biosimilars

A biosimilar (also known as a follow-on biologic or subsequent entry biologic) is a product produced by two different pharmaceutical companies that are essentially the same drug. Often times multiple companies will come up with biosimilars but offer them at a lower price in order to be competitive in the market.

This year was particularly brutal for biosimilar appeals; drugs like Cellrion’s Inflectra- nearly identical to Janssen Biotech’s Remicade- was nontheless approved by the FDA.

As the FDA continues to approve and accept safe and effective biosimilars, many have begun to wonder what reception these copycat drugs can expect to receive from prescribing physicians.

According to a survey conducted by the Biosimilars Forum, 91 percent of US physicians said they would be willing to prescribe a biosimilar over its branded biologic. Other results of the survey however, suggested that doctors would benefit from a better education of how the approval process for biosimilars differs from branded drugs, in order to ensure they have the most accurate information to help them make prescribing decisions.

References

https://xtalks.com/Doctors-Willing-To-Prescribe-Biosimilars-534/

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Trump and Biotech

Last week I talked a little bit about what Brexit means for the biotechnology sector in the UK: now I want to bring your attention to an event a little closer to home- Trump. 

Barring any political opinions I have of that orange buffoon, it’s time to face the possibility that a Trump presidency could become a real thing. And that leads to some very interesting speculations about what that could mean for the pharmaceutical and biotechnology industry in the US.

“I’m going to bring down drug prices,” Trump said, according to a transcript of an interview posted on Time magazine’s website as it named him its Man of the Year. “I don’t like what’s happened with drug prices.”

In this interview Trump suggested allowing the re-importation of pharmaceuticals from other countries to get drug spending under control. While this strategy could alleviate some of the drug affordability issues that plague the healthcare system in the US, it would require the government to remove the barriers that currently prevent this practice.

Then again, this is all coming from a man who doesn’t believe in climate change, so I would take his scientific opinions with a grain of salt.

What Brexit Means for Biotech

Current events!

As I’m sure we’re all aware of, around 2 months ago the United Kingdom voted to withdraw from the EU. Generally speaking, this was a big move for the UK- and with that move came global ramifications pertaining not only to the politics or the economy of the EU, but also in the field of biotechnology.

Following Brexit, there was a major plummet in the biotech market, as uncertain investors started pulling away from the UK market. Celgene and Regeneron lost over 4% during the will-they won’t-they atmosphere that surrounded the UK this summer, and Gilead dropped to a two-year low. Right after it was announced that the UK would withdraw from the EU, the iShares NASDAQ Biotechnology Index fell 3%.

Many have attributed this phenomenon to the uncertainty surrounding the new regulations that the UK will place on its biotechnology sector, as well as the fact that it will lose significant funding for biotech research from the rest of Europe.

References: https://investingnews.com/daily/life-science-investing/biotech-investing/brexit-biotech/

 

 

Controversy Over Immunotherapy Trial Deaths

Cancer research is undoubtedly on the rise. One relatively new method of looking at possible treatments is the use of immunotherapy, where doctors try to use the patient’s own immune system to stave off malignant growth and cancer cells.

This research has suffered a setback recently, however, as 3 patients died as a result of being treated with CAR-T cell therapy by Juno Therapeutics. These patients were hopeful participants in a novel form of immunotherapy called JCAR015, which targets B-cell acute lymphoblastic leukemia. Juno attributed the deaths to a chemotherapy drug that was administered pre-CAR-T therapy that was designed to better prepare the body for the introduction of artificially manufactured T-cells.

This is a huge blow for the field of immunotherapy, which many have regarded as a revolutionary treatment for the future in treating cancer patients. Still, I believe that trials should continue, and that biotechnology and biomedical engineering will play a much greater role in healthcare.

 

References: https://www.biopharmadive.com/news/juno-car-t-trial-fda-patient-deaths/422254/