January 19, 2011
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In our original post on biosimilars, Lumira Capital’s Beni Rovinski set out the business opportunities, the technical challenges and the regulatory hurdles facing follow-on biologics in 2009. Since then, as Beni predicted, a series of pharma deals have followed Merck’s Insimed acquisition, and the regulatory framework in North America has been clarified substantially, with final Health Canada guidance having been issued and the the U.S. BCPI Act working its way through the FDA’s rule-making process.
The biosimilars market has also evolved in a couple of unexpected ways:
- Teva decided not to wait for a distinct U.S. biosimilars pathway, and instead submitted a full BLA for Neupoval (which was accepted). Although Neupoval’s approval is now delayed, with the 12-year exclusivity period in the BCPI Act far exceeding similar periods in the EU and Canada, more companies may follow Teva’s approach instead of navigating the U.S. biosimilar regime.
- At the JP Morgan conference last week, the CEO’s of Amgen and Biogen Idec, two companies that have been built on innovator biologics, both openly discussed their own plans to produce biosimilars. Although Amgen’s Sharer said the company “should participate in an intelligent way without disturbing the core business,” and was looking to Asian and Latin American markets, Biogen Idec’s Scangos said flatly that “[t]he next decade will be about access and cost as much as it is about innovation,” and that biosimilars are “a low risk way to generate substantial revenue.”
As the regulatory and business environments continue to evolve, we’ll continue to keep an eye on the latest developments.
This post is the fourth in a series briefly outlining the biotech industry trends we’ve been following on the blog and noting some recent developments, plus directions for 2011.
February 2, 2010
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Teva’s decision last year to submit a full biologic license application (BLA) for Neupoval looks positively prescient today. Teva’s product is already sold in the EU as a biosimilar to Amgen’s Neupogen, but a U.S. biosimilars pathway is stalled along with the rest of health reform and today, the FDA accepted Teva’s BLA, clearing the way for a review of Teva’s clinical data and potentially for approval of the product.
FDA approval isn’t Teva’s only hurdle, though. Amgen’s U.S. patents on Neupogen don’t expire until 2013, and the two companies are currently litigating the issue of whether Teva’s product infringes those patents. Furthermore, the Dow Jones article quotes Credit Suisse analyst Michael Aberman who points out that in the EU Teva’s product only has 5% market share, competing against both the original Neupogen and Amgen’s longer-acting Neulasta.
Investors’ reaction? Teva shares were up 1.4 percent, Amgen shares were off minutely.
My bottom line: If you want to read tea-leaves to predict the approach other biosimilar products will take (and I do), watch the Neupoval BLA closely. The calculus undertaken by other potential market entrants will weigh Teva’s success and costs with this approach against the costs of any Congressional requirement for data exclusivity period and any FDA requirement for clinical trials in an eventual biosimilars regime.
Follow our coverage of North American biosimilars news on this Biotech Trends in 2010 page.
October 29, 2009
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As part of the Gairdner Foundation’s 50th anniversary celebrations this week, there was a breakfast panel this morning with a lot of brainpower (even for MaRS). Cal Stiller lead a discussion by David Baltimore, Phillip Sharp and Corey Goodman who between them have three Gairdner awards and two Nobel prizes.
These top-notch scientists also have truly impressive corporate expertise: Board members of Amgen, Biogen and Limerick BioPharma. They turned their attention to “unclogging the pipeline.”
David Baltimore discussed reasons we’ve seen fewer approvals:
- Higher regulatory safety barrier.
- Low-hanging fruit is gone. A lot of targets are for diseases that are not fatal in the short term, which (see #1) creates a high safety barrier. Also, he says the molecular targets are harder.
Baltimore also identified potential areas of success: a subject area (immunotherapy) and a structural area (UCLA medical center’s translational research institute).
Phillip Sharp talked about the changing structure of early stage and translational funding.
- VC is re-thinking their model, but pharmas are reaching out earlier in the pipeline with incubators and academic outreach; and there is more public funding available to move products further along the pipeline.
- Trends he identifies: personalized medicine (patient-driven with $1000 genome); and a huge role for engineers and incremental improvements.
Corey Goodman starts with some stats:
- current success rate is closer to 1 in 25, not the 1 in 10 number still cited from the 1990′s
- cost of a new drug (R&D dollars divided by successful approvals) around $3 billion.
Nevertheless, Goodman sees upside due to huge unmet medical needs, deficient pipelines and vast academic output.
Will healthcare reform plans interfere with the United States’ (hidden) subsidization of global drug development through high prices?
- Baltimore points to $80 billion pharma deal that avoided price controls, but says prices are unsustainable.
- Sharp agrees that costs can’t be a bigger part of GDP, but it’s a big bucket even at current levels and there is room for efficiencies that don’t impact reimbursement.
- Goodman says importation can’t be prevented long-term based on a safety argument, so we’ll have to deal with pricing more globally [regardless of U.S. health reform efforts].
Aren’t early-stage acquisitions still (and permanently) the outliers?
- Baltimore thinks there will be a number of early-stage transformative technolgies that yeild early successes, but VC and other early funders need to be more stringent and keep an eye on the long term potential of even very early stage products.
- Sharp thinks that academia is not well-suited to disciplined discovery, and if the policy goal is to develop more products, we’ll need structural changes in academia.
The panel wrapped up on an optimistic note. Not surprising — how can you not feel good in Gairdner season? Speaking of Gairdner season, don’t forget to check out this year’s winners.
August 11, 2009
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A few weeks ago, when the FDA changed the labeling on anti-EGFR drugs, Amgen was pretty enthusiastic about “avoiding unnecessary treatments in patients [with a specific genetic marker] who are unlikely to benefit” from Vectibix. Avoiding these patients leaves more reimbursement available for patients who would benefit from Amgen’s product.
Now Amgen has even better data to support its personalized approach to colorectal cancer treatment: their study of Vectibix as a first-line treatment tracked the KRAS genetic status of participants and showed “significantly prolonged progression-free survival” for the wt-KRAS group.
In patients with mutated KRAS, Vectibix wasn’t just “unnecessary,” it actually showed worse outcomes than the control group, meaning genetic testing of all colorectal cancer patients will be a top priority.
A second important note for companies thinking about companion diagnostics and personalized effectiveness is that the Amgen study was a prospective study that will support much more robust conclusions. H/T @ldtimmerman.
In contrast, recall that the CMS decision not to reimburse genetic testing for Warfarin dosing specifically cited the lack of prospective data on which to base a decision.
This new data from Amgen will:
- Drive tumor genotyping as a standard of care; and
- Help make the economic case for companion diagnostics.
July 20, 2009
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This is exactly how personalized medicine and comparative effectiveness can interact to benefit patients, pharma companies and payors:
- data shows that patients with KRAS mutations don’t benefit from anti-EGFR antibody meds Erbitux or Vectibix;
- the FDA approves a labeling change identifying the patients who won’t benefit;
- payors see costs savings from eliminating pointless prescriptions;
- patients without the KRAS mutations have added incentive to take the drugs, benefiting themselves and the pharma companies who make the drugs.
As the WSJ Health Blog says:
“Erbitux and other expensive cancer medicines have faced repeated questions about whether drugs that prolong life for short periods of time are worth the high costs… Not using Erbitux as a first-line treatment for [KRAS-variant] patients could save about $600 million a year.”
The manufacturers Bloomberg’s reporter spoke to are fully supportive:
“‘The inclusion of KRAS as a biomarker in the Erbitux labeling helps physicians to better understand the most appropriate use of the drug in the management of patients with metastatic colorectal cancer,’ said Fouad Namouni, an oncology executive for Bristol-Myers …
Physicians can eliminate Vectibix and Erbitux for colon cancer patients with the KRAS mutation and ‘redirect those patients to alternative therapies, avoiding unnecessary treatments in patients who are unlikely to benefit,’ said Sean Harper, Amgen’s chief medical officer.”
February 19, 2009
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In Beni’s post earlier this week on Biosimilars, he identified two major challenges to introducing follow-on biologics into the North American market: technical proficiency, and the absence of a regulatory regime.
Based on the approval of Teva’s biosimilar version of Neupogen in the EU last September, Teva has evidently cleared the first hurdle (and their joint venture with Lonza means their technical capabilities will only increase).
Yesterday, Teva announced that they were not waiting for a Biosimilars regime to be enacted before entering the U.S. market, and instead will take on the extra cost of filing a full BLA for their version of the biologic.
Does this mean we don’t need a biosimilars regime to get biosimilars to market? Teva itself takes a different position.