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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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July 26, 2010

Biosimilars: Not Easy, But Not Impossible, Either

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Posted by Derek

So we actually had two converging stories on Friday afternoon - the news that Sanofi-Aventis is going after Genzyme, and the news that tiny Momenta Pharmaceuticals finally got FDA approval for a biogeneric of Lovenox (enoxaparin). . .a big seller for Sanofi-Aventis.

I knew something was going on with those folks - I'm close enough in Cambridge that I could hear them whooping and popping champagne corks. They've got backing from Novartis, who will actually be making the stuff using Momenta's techniques, but this was make-or-break news for them, and they've been waiting for quite a while to hear it. Meanwhile, Sanofi-Aventis has been hoping just as long that this day wouldn't come.

And they're not alone. A lot of companies have built their business model around the fact that it's very hard to produce biosimilars, so anything that chips away at that is a potential attack on their profits. Genzyme is very much one of those companies, and Shire is one of the companies hoping to move them into the new world.

Every biologic product is different, though, and some of them are going to be harder to break than others. But the financial incentives for doing so are there, and Friday's approval makes them more definite than ever. As a small-molecule guy, I'm not all that sad about this, although that may be an unworthy emotion. I think that some sort of exclusivity (which we now grant mostly through the patent system) is necessary for research companies to turn a profit. But that exclusivity shouldn't be perpetual, either. Everyone should have an incentive to look for the next new thing - hoofbeats, coming up from behind, should be the constant background sound.

Comments (12) + TrackBacks (0) | Category: Business and Markets | Regulatory Affairs


COMMENTS

1. Ty on July 26, 2010 9:58 AM writes...

Lovenox is a... biologic drug? Surely it's not a conventional small molecule, but, still. It's farther from conventional biologic, I think.

Permalink to Comment

2. stuff on July 26, 2010 10:45 AM writes...

There are a number of biosimilar products already approved in the EU, most of which ate insulins or interleukins.

There is a pathway to approval in the EU, which requires clinical trial evidence that the biosimilar is able to perform the same action as the originator product.

The EU has taken into account namimg and labelling requirements, whether or not there can be substitution of a biosimilar for an originator product etc. It was interesting that the EU got on with getting a process in place that had patient safety at its heart, while in the US muchof the argument has been about how much patent protection there shoudl be.

No mAbs have been approved yet and the EMA has recently consulted on this.

I think that mAbs will prove to be quite a big challenge for approval as biosimilars, and think that companies may be better off just trying to get a direct approval as a better version of the originator.

The difficulties Genzyme has had with the scale up of manufacturing of Myozyme (Lumizyme) from a small vessel to a larger vessel and the changes in the glycosylation are, I feel, only a precursor of what will happen with mAbs.

Permalink to Comment

3. Cellbio on July 26, 2010 12:41 PM writes...

Hey Derek,

I am a biotech guy and think the arguments for biosimilar challenges are inflated. The EU will certainly lead the US in policy in this area and success of biogenerics will undermine the case made by marketers of brand name biologics.

However, don't really see Lovenox as a biological as Ty points out.

Stuff- you make a good point about mabs, and most outfits pursuing established markets move forward with a mab that binds the same target, but is a novel molecule with unique heavy and light chains, or with unique engineering of the parent to alter features such as ADCC, PK, manufacture in bugs, drug-conjugated. Not aware of any pure biosimilars. Anyone know of any?

Permalink to Comment

4. Petros on July 26, 2010 12:50 PM writes...

The FDA doesn't regard Lovenox, or insulins and certain other peptides as biologicals, but as drugs. Because they were approved after filing NDAs the established pathway for generic approvals applies. The fun will start when someone seeks approval of a biosimilar using the recently passed legisaltion.

Although the EU leads the way, biosimilars are also now approved in Japan where another pathway has been established

Permalink to Comment

5. Neigh on July 26, 2010 1:55 PM writes...

Just as long as your horse hoofs don't become a stampeed at the expense of human safety by trampling on the innocent.

Permalink to Comment

6. andrew c on July 26, 2010 5:34 PM writes...

wow enoxaparin finally going generic. we use this on almost every patient in our hosptial.

Permalink to Comment

7. thumperska on July 27, 2010 7:25 AM writes...

Glycosaminoglycans such as heparin, from which Lovenox is made, are organic molecules made from carbon, oxygen, nitrogen and sulfur. It is made from the mucosa of pig intestines. So, yes, Lovenox is a biologic it's just not made in a fermenter like most drugs that you think of as biologics. I think if that Lovenox were to be approved today, it would have to be approved through a BLA pathway instead of an NDA.

Biogeneric legislation was included in the giant healthcare bill passed this year. The innovator product is protected for 12 years begining with the date that it is first marketed.

http://www.govtrack.us/congress/bill.xpd?bill=h111-3590

Permalink to Comment

8. Anonymous on August 1, 2010 3:47 PM writes...

My worry about outsourcing heparin analogs is based on recent reports. Remembr the heparin scare from china? Somehow chondroitin got into the API. Was it a fluke or a scientific blunder. If you're a med chemist, compare the structures. Obviously, someone is thinking. I worry bout this in the future. There's always someone ahead of you trying to make a buck. Foreign API should be scrutinized before entering this country. if that's a problem with the foreign source, then we should cut off them off and do it " in house". Yes, make it is the US, and keep the jobs here. Stop the outsourcing...

Permalink to Comment

9. Anonymous on August 1, 2010 4:06 PM writes...

Oh yeah, I forgot to mention. Watch out for products with lead (or possibly other nasty heavy metal) based paint. Perhaps it's just time before they make it to your IPOD, Iphone or IToys (Trade mark? LOL) or others. I thought lead dissappeared in the early 70's. Humm....

Permalink to Comment

10. Ashritha on October 5, 2010 8:33 AM writes...

My colleagues and I have authored what we believe is India’s first ever complete mapping of the Biosimilars opportunity in India. The report is nowbeing made available to the general public.
Various issues have been dealt with, such as:
- Patent expirations
- Regulatory frameworks
- Infrastructure Requirements
- Etc.
If anyone is interested in this report, please contact me at (infoalcpl AT gmail DOT com), and I would send you the brochure and other details.

Permalink to Comment

11. Ashritha on October 5, 2010 8:34 AM writes...

My colleagues and I have authored what we believe is India’s first ever complete mapping of the Biosimilars opportunity in India. The report is nowbeing made available to the general public.
Various issues have been dealt with, such as:
- Patent expirations
- Regulatory frameworks
- Infrastructure Requirements
- Etc.
If anyone is interested in this report, please contact me at (infoalcpl AT gmail DOT com), and I would send you the brochure and other details.

Permalink to Comment

12. Nayan on March 2, 2011 11:54 PM writes...

Me and my colleagues authored one of India's most extensive reports on Biosimilars. Drop me a mail if you are interested in a copy. My email is ntaluk@gmail.com.

Some of the topics we included are:

- Market Trends
- Growth Drivers
- Regulatory Bodies and Framework
- Major Players.
-Etc.
We interviewed over 200 individuals and firms to collect the data in what we believe is one of the most detailed study on the subject in India.

Nayan
ntaluk@gmail.com

Permalink to Comment

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