Perhaps the most significant development during 2011 was the progress in the US biosimilars pathway, as part of the Biologics Price Competition and Innovation (BPCI) Act of 2009. Despite the BPCI Act being signed into law by President Barack Obama in March 2010, and the statement from FDA that it hoped to issue the first of what will be several guidance documents on biosimilars before the end of 2011, formal guidance has still not been issued.
Some progress has been made, however. FDA held a 2-day public meeting in October 2010 to gain input on the act’s implementation from interested parties [1] and outlined some of the requirements it intends to include in its biosimilars approval process in an article published in August 2011 in the New England Journal of Medicine [2].
The agency has also published draft proposals on biosimilar user fees, arranging a public meeting on 16 December 2011 to discuss its recommendations [3]. FDA must submit its proposal for creating a biosimilars user fee programme to Congress by 15 January 2012, which is expected to be passed in 2012 along with the Prescription Drug User Fee Act reauthorisation [4].
In Europe, EMA has been busy drafting new guidelines during the last year. The long-anticipated draft guideline for biosimilar monoclonal antibodies was published in November 2010 and was open for public consultation until May 2011. In the meantime, EMA has also produced concept papers to revise three of its overarching biosimilars guidelines (general, clinical and non-clinical issues and quality issues). The EMA expects draft revised guidelines to be released in the first quarter of 2012 [5].
Due to confusion over terms, EMA also proposed a more precise definition for biosimilars due to problems arising from imprecise usage of the term biosimilar in the literature. EMA found that in some cases the term biosimilar had even been used incorrectly to describe counterfeit medicines [6].
In January 2011, Sandoz, the generic drug division of Swiss pharmaceutical giant Novartis, announced that it was starting a phase II clinical trial for a biosimilar version of monoclonal antibody rituximab. Sandoz is already the only biosimilars manufacturer to have more than two biosimilars on the market and is set to be a market leader, with 8–10 molecules at various stages of development [7].
In September 2011, Hospira announced positive results from its phase I clinical trial of a biosimilar erythropoietin (EPO) in the US in patients with anaemia associated with chronic renal failure and chemotherapy. Hospira’s trial met its key endpoint, showing equal pharmacokinetics, or concentration levels in the blood and distribution in the body, as well as equivalent safety, for Hospira’s EPO and the reference product, Amgen’s Epogen [8].
One negative development that has recently overshadowed the positive trend for biosimilar medicines in the last year is the inclusion in the Trans-Pacific Partnership agreement of a 12-year exclusivity period for originator biologicals [9]. This comes despite president Obama’s proposals for a 7-year exclusivity period in his 2012 budget plan for economic growth and deficit reduction and despite the fact that the biosimilars pathway is still not finalised [10].
On the bright side, biosimilar deals have definitely been popular during 2011. Some notable deals include those of generics giant Teva and biologicals firm Cephalon, Indian generics manufacturer Lupin Pharmaceuticals and biotech firm Neuclone, and German generics giant Stada Arzneimittel’s monoclonal antibody deal with Hungary-based Gedeon Richter. Big Pharma is also still joining the fray, with Boehringer Ingelheim announcing in September 2011 the creation of a dedicated biosimilars division.
Non-pharma have also been getting in on the act, with Japanese digital camera maker Fujifilm entering into a biosimilars deal in November with biotech firm Kyowa Hakko Kirin. Korean electronics giant Samsung has also followed suit, making biosimilars deals with contract research organisation Quintiles and more recently with US biotechnology specialist Biogen Idec.
In fact, the South Korean Government is actively promoting the biosimilars industry in order to make South Korea a market leader. The government is providing both financial and institutional support and is aiming to take a 22% share of the global market by 2020 [11].
Despite there still not being an established biosimilars pathway in the US Amphastar finally received marketing authorisation from FDA in September 2011 for its biosimilar version of sanofi-aventis’s blockbuster blood-thinner Lovenox (enoxaparin) [12]. The news, however, is bittersweet because although Amphastar finally received FDA approval almost eight years after its original abbreviated new drug application was filed in 2003, a federal court injuction prevents the generics company from marketing the drug. Some also argue whether enoxaparin, as a low molecular weight heparin, is really a biosimilar or not [13].
Finally, in June 2011 FDA and EMA announced that they had agreed to collaborate on the exchange of information on biosimilar drugs [14].
With the US slowly moving towards implementing practical guidance for their biosimilars pathway and further more specific guidelines emerging in Europe, the future looks bright for the next year in the biosimilars market.
Related articles
Samsung makes biosimilars deal with Biogen Idec
Fujifilm and Kyowa Hakko Kirin in biosimilars joint venture
Boehringer Ingelheim joins other Big Pharma going into biosimilars
Stada and Richter to collaborate on biosimilar development
Lupin and Neuclone biosimilars agreement
Teva grabs biopharmaceutical company Cephalon
Highs and lows for biosimilars during 2009/2010
References
1. GaBI Online - Generics and Biosimilars Initiative. FDA holds public hearing on biosimilars pathway [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/News/FDA-holds-public-hearing-on-biosimilars-pathway
2. GaBI Online - Generics and Biosimilars Initiative. FDA and biosimilars – process update [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/General/FDA-and-biosimilars-process-update
3. GaBI Online - Generics and Biosimilars Initiative. FDA and biosimilars – process update [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: http://gabionline.net/Biosimilars/General/FDA-biosimilar-user-fees-meeting
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar user fees proposal under review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-user-fees-proposal-under-review
5. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
6. GaBI Online - Generics and Biosimilars Initiative. EMA proposes more precise definition for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/Research/EMA-proposes-more-precise-definition-for-biosimilars
7. GaBI Online - Generics and Biosimilars Initiative. Sandoz announces biosimilar rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-announces-biosimilar-rituximab
8. GaBI Online - Generics and Biosimilars Initiative. Positive results for Phase I trial of biosimilar erythropoietin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/News/Positive-results-for-phase-I-trial-of-biosimilar-erythropoietin
9. GaBI Online - Generics and Biosimilars Initiative. Debate over biosimilars exclusivity period in free trade agreement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Generics/News/Debate-over-biosimilars-exclusivity-period-in-free-trade-agreement
10. GaBI Online - Generics and Biosimilars Initiative. Generics and biosimilars affected by President’s deficit plans [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/News/Generics-and-biosimilars-affected-by-Obama-s-deficit-plans
11. GaBI Online - Generics and Biosimilars Initiative. Biosimilars boost for South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/News/Biosimilars-boost-for-South-Korea
12. GaBI Online - Generics and Biosimilars Initiative. Amphastar’s biosimilar enoxaparin approved by FDA – Momenta launches lawsuit [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/News/Amphastar-s-biosimilar-enoxaparin-approved-by-FDA-Momenta-launches-lawsuit
13. GaBI Online - Generics and Biosimilars Initiative. Enoxaparin biosimilar or not [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/General/Enoxaparin-biosimilar-or-not
14. GaBI Online - Generics and Biosimilars Initiative. EMA and FDA to collaborate on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 January 13]. Available from: www.gabionline.net/Biosimilars/News/EMA-and-FDA-to-collaborate-on-biosimilars
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