Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Biosimilar Drug Names Mean a Lot in Terms of Saving Money

Biosimilar Drug Names Mean a Lot in Terms of Saving Money | Pharmaguy's Insights Into Drug Industry News | Scoop.it
What's in a name? A lot, according to groups battling over whether biosimilar pharmaceutical products should be allowed to use the same nonproprietary name as branded products.


In March, in its first approval of a biosimilar product, the Food and Drug Administration designated the Sandoz product Zarxio with the placeholder nonproprietary name “filgrastim-sndz.” That was a compromise from labeling it simply as filgrastim, the nonproprietary name for the brand-name product, Neupogen, for which it is considered a biosimilar. 

Experts estimated that Zarxio could be sold at a discount of up to 35% of the price of Neupogen, a blockbuster cancer biologic produced by Amgen, which can cost about $3,000 for 10 injection treatments.


Some estimates have projected the biosimilars market in the U.S. will grow to $60 billion by 2020 as the patent protections on a number of biologic medications are set to expire over the next several years.


An Express Scripts report estimated that as much as $250 billion could be saved over the next decade if biosimilars being developed are approved for 11 biologic drugs that are slated to lose patent protection in the coming years.


“In the near term, the first-order obstacles (for the biosimilars industry) are the lack of interchangeability and the prevention of automatic substitution,” said Andy Pasternak, a partner and healthcare analyst at Bain & Co. in Chicago, a management consulting firm. “Once products overcome those, the naming issue becomes more significant.


Developers of biosimilar products such as Sandoz have been mired in legal battles for the past several years with manufacturers of branded biologic products that seek to block or delay the introduction of biosimilars. In addition to the lawsuits, biosimilars also face regulatory challenges that could slow their growth, Bain analyst Pasternak said. A key issue is interchangeability. 

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#Pharma & Biotech: Biologics Are Where the Money Is!

#Pharma & Biotech: Biologics Are Where the Money Is! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Considering all the biotech and pharma M&A activity, isn’t it about time we just combine the two and start referring to it as one — the biopharmaceutical industry?


Consider this, of the top 10 bestselling drugs for 2014, 80 percent were biologics (see table 1). 


Table 1

8 of Top 10 Bestselling Drugs of 2014 are Biologics


           Drug - BioPharma Co - Sales ($ Billions)

  1. Humira - AbbVie - $12.54
  2. Sovaldi - Gilead - $10.25
  3. Remicade - J&J/Merck - $9.24
  4. Rituxan - Roche/Biogen - $8.68
  5. Enbrel - Amgen/Pfizer - $8.54
  6. Lantus - Sanofi - $7.28
  7. Avastin - Roche - $6.96
  8. Herceptin - Roche - $6.79
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AbbVie Has Room to Cut Its $203 Million Humira Ad Budget, Say Analysts. But Why Bother?

AbbVie Has Room to Cut Its $203 Million Humira Ad Budget, Say Analysts. But Why Bother? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

With biosimilars makers eager to grab a piece ofHumira's $12.5 billion-plus revenue, copies of AbbVie's ($ABBV) blockbuster are on their way. What analysts disagree on, though, is when they'll arrive and how long it'll take them to make their presence known--and a pair of UBS analysts, for one, thinks the Illinois pharma has some marketing maneuvers up its sleeve to minimize their impact.


According to UBS analysts Marc Goodman and Ami Fadia, should the entry of Humira biosimilars put branded sales on a serious downswing, AbbVie has some room to pare down costs. Right now, it ranks as the No. 2 ad spender in Big Pharma, and last year it shelled out 56% of its budget--$203.2 million--on advertising the drug.

Pharma Guy's insight:


File this one under "You don't need an analyst to know which way the wind is blowing." But I guess $200 Million is not a lot considering Humira sales are about $8 BILLION annually. Thus, the marketing budget is less than 3% of sales! Even if Humira lost 50% market share, which often happens when generics hit the market, AbbVie can still spend $200 Million on adverting and that would be just 5% of sales!

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37% of New Drugs Approved by FDA in 2014 were for Treatment of Rare Diseases

37% of New Drugs Approved by FDA in 2014 were for Treatment of Rare Diseases | Pharmaguy's Insights Into Drug Industry News | Scoop.it

New data from the FDA (here) shows that 2014 was a banner year for orphan drugs, which are drugs that treat "rare" diseases/disorders affecting fewer than 200,000 people in the U.S.


Orphan drug approvals represent 37% of all new drug approvals in 2014. Today, orphan drugs have the potential to turn into blockbusters with annual sales over $1 Billion.


Read more here.


Pharma Guy's insight:


When a dumb reporter asked "Willie" Sutton, the famous bank robber, why he robbed banks, he is reported to have said "Because that's where the money is." Duh!

Until a few years ago, if you asked a pharmaceutical company executive why his or her company developed and marketed an "orphan drug" -- ie, a drug for a disorder affecting fewer than 200,000 people in the U.S. -- you would likely have gotten a response such as "because there is an unmet medical need" or something similar.

Today, however, orphan drugs also have the potential to turn into blockbusters; ie, be where pharma's money is at.


Read, for example, "New Big Pharma Economies of Scale: Less Patients Needed to Reach Blockbuster Sales")

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