Are biosimilars the new generics? 4 thoughts with industry expert Dave Picard

Biosimilar drugs are highly similar, although not exact, versions of biologic drugs. With a handful of these treatments already approved by the Food and Drug Administration — and dozens of others coming down the pipeline — biosimilars are poised to disrupt the drug industry in terms of both care and cost, similar to how generics transformed the industry in the 1980s.

Dave Picard, vice president of biosimilars and injectables at AmerisourceBergen, holds more than 25 years of experience in the generic pharmaceutical industry.

Prior to joining the AmerisourceBergen family in September 2014, Mr. Picard served as the vice president of institutional sales at Sandoz, the generic drug unit of Novartis Pharmaceuticals, and spent 11 years at Bristol-Myers Squibb in various sales and marketing roles. He earned his bachelor's degree from the University of Central Florida in Orlando and an MBA from Robert Morris University in Chicago.

Mr. Picard recently spoke with Becker's Hospital Review about biosimilar drugs and their role in the pharmaceutical industry.

Note: Responses have been lightly edited for style and clarity.

Question: Do you think biosimilars will be a valid solution to high prescription drug costs?

Dave Picard: These products are "biosimilar," meaning they cannot claim any improved efficiency or safety profile compared to the biologics they mimic. So really, what do they have to offer the marketplace, the customer or the patient? It's really an economic incentive. I think the first wave of biosimilars will offer 15 to 20 percent savings and will be similar to when a single generic drug enters a branded market. Price reduction will start to look more like generics in the future when there are two to three competitors for the same molecule. With that said, I don't think the biosimilar market ever will or ever should look quite like the generic space. There are too many patient services in place and there's a cost to those services. The pricing won't really support going to 80 percent off the brand price for these specialty products.

On the flip side, the investment needed to produce a biosimilar can be upwards of $100 million dollars. With that kind of investment — compared to a $3 million investment for a typical generic — pricing can't afford to go to that generic-type model, nor should it. I think its going to remain somewhere in between those two models for some time.

Q: What is the greatest challenge biosimilar drugmakers are facing right now?

DP: It's really going to take repetition and education to get people comfortable with using biosimilars. The generic market was created in 1984. It took quite some time for us to get to where we are now where 88 percent of prescriptions are filled with a generic. I don't know if that's a perfect analogy of what the biosimilar space will look like, but it's certainly going to take time for early adopters to start giving biosimilars to patients before others say "hey this works, let's jump in."

Major drug companies will have a leg up when they roll out biosimilars, since physicians and providers have a long history of experience with them and are more likely to trust their new medications, compared to those from a small, unknown biosimilar company.

Q: Why is the U.S. biosimilar market lagging so far behind Europe? Are there any advantages or disadvantages to the U.S. market being so much younger?

DP: Europe has been at it for about 10 years longer than we have. Its regulatory pathway was established prior to the FDA's. There is a lot of information and patient days of experience data coming from Europe we can benefit from. Interchangeability as a term doesn't really exist in Europe, but we see biosimilars being treated as interchangeable like generic drugs. A lot of these different countries put out bids and will take on whatever biologic or biosimilar comes with the best price. So we're seeing interchangeability occur both for naïve and existing patients. I've yet to hear of any issues with it, so it's the European experience will provide great data for us to learn from.

I think the FDA is taking this information into account when it's going through its filings and approvals. It has been taking a very conservative stance with biosimilars, because it wants to make sure it gets this right. It took the ACA for this to become a potential reality. If that does get repealed, I hope this piece of it gets saved.

Q: Where do you see the future of biologics? Any trends you predict?

DP: For patients with high-cost, high-touch diseases, I think that biosimilars entering the space, will improve access and affordability. There are about 60 projects in play now with FDA's biosimilar and biologic projects. In the next 10 years, I think we're going to catch up to Europe and see approvals speed up. I believe the FDA has already stated they aren't going to hold advisory council meetings for every subsequent biosimilar filing of a product that's already been approved.

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