A shingles vaccines and biologic generics

There’s been a lot in the news about vaccines. Cervical cancer vaccines, avian flu vaccines, vaccines for ear infections. Now Merck has another new vaccine that has just been approved by the FDA to treat shingles in people age 60 and over. Shingles is typically treated with Valtrex or another antiviral once it flares up. Zostavax, though, keeps the virus from flaring up before it happens, and it is the only pharmaceutical capable of doing so.

This is just the latest trend in a newly-rekindled vaccination industry. Turns out there’s money in vaccines after all.

But analysts reckon the vaccine market will grow much faster than the market for prescription drugs. “We’re in a period where pharmaceutical sales are growing at 5% to 6% a year,” says Novartis Chief Executive Daniel Vasella. “In contrast, the vaccine industry is looking at nearly 20% annual growth over the next five years.”

I tend to take what analysts think with a grain of salt, because I get fed up with their near-obsessive emphasis on quarterly earnings, but they’re probably right in this case. Biologics are heating up, and vaccinations are a big part of this. Along with expensive, niche biologic drugs, vaccines will probably be consistent money-makers for Big Pharma. The reason for this is is that it’s quite difficult to get a generic biologic approved by the FDA. It can be done, but the FDA had to create a new way to approve these “generics,” but this precedent of sorts may not hold water for other biologic generics:

The FDA said the approval did not set a precedent for other copycat biologics. Human growth hormone is one of the better understood protein compounds, making it possible to compare brand name and generic versions, it added.

“The approval of Omnitrope … does not establish a pathway for approval of follow-on products for biological products … nor does it mean that more complex and/or less well understood proteins approved as drugs under the Food, Drug, and Cosmetic Act could be approved as follow-on products,” the FDA said in a statement on its Web site.

Unfortunately I cannot find the source of the quote, but in any event, it will be interesting to see what happens when more biologics start going off-patent. Will they still be big money-makers for Big Pharma due to bioequivalency issues? Or will have generic drugmakers have figured out ways around these potential roadblocks by that time?

It’s easy to think that the generic companies will have figured something out by then, but I am reminded of the bioequivalency issues that generic manufacturers had with drugs like Lanoxin (digoxin) and Synthroid (levothyroxine) for quite a few years. It’s not as easy as firing up a photocopier, particularly with complex biologic drugs.

5 thoughts on “A shingles vaccines and biologic generics

  1. Shingles is typically treated with Valtrex or another antiviral once it flares up. Nice Article, I would like to bookmark it

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