Global Insight Perspective | |
Significance | Valtropin, produced by Swiss biopharmaceutical company Biopartners, is the second biosimilar drug ever approved in the European Union (EU). |
Implications | Valtropin is expected to be launched by year-end and will compete against the originator biotech drug as well as against Novartis' (Switzerland) biosimilar copy of human growth hormone. |
Outlook | Novartis' Omnitrop was launched at a 20% discount to the originator product in Germany and an Austrian launch is also imminent. In order to compete successfully, Biopartners will have to offer Valtropin at a similar discount. Prices of biosimilars are expected to remain relatively high compared to the originator product in light of production difficulties and high barriers to market entry. |
Biopartners Becomes Second Company to Secure EU Approval for a Biosimilar
Swiss biopharmaceutical company Biopartners announced on 4 May that its biosimilar copy of human growth hormone had been granted marketing approval by the European Commission for the treatment of human growth deficiency in children and Turner's Syndrome. The approval came after the EMEA's CHMP committee issued a positive recommendation for approval in late February.
This approval is the second ever approval of a biosimilar drug (a copy of a biotech medicine) in the European Union (EU). The first approval – also for a copy of human growth hormone (Omnitrop from Sandoz, the generics division of Novartis) - was issued in April 2006, following a long evaluation process, an initial rejection by the Commission (despite a positive EMEA recommendation) and an eventual lawsuit from Novartis against the European Commission.
Valtropin was co-developed by Biopartners and LG Life Sciences Ltd (South Korea). Following an in-licensing agreement, Biopartners acquired the rights to sell Valtropin in Europe, Japan and parts of Asia. The drug is to be launched in the EU by year-end, according to Biopartners' statement.
In addition, Biopartners is developing a sustained release formulation of Valtropin (currently in Phase III trials) with LG Life Sciences. The company has also submitted a second approval dossier to the EMEA – for a biosimilar version of interferon alfa, according to NHS News and Updates.
Outlook and Implications
There was little doubt that the European Commission would approve Valtropin this month, following the positive European Medicines Agency (EMEA) recommendation in February and the Commission's approval of Omnitrop. And yet, this approval is a significant milestone – both for Biopartners and for the biosimilars approval process in general.
The second approval signifies that there is no going back to the time of perpetual delays and excuses that a regulatory process for biosimilars approval was not in place. Novartis' Sandoz may have borne the brunt of the struggle to win biosimilars approval and incurred the legal costs, but the abbreviated-approval guidelines for biosimilars in the EU are now firmly in place and other drug-makers will also gain access to this exciting and potentially extremely lucrative market.
With the approval, Biopartners establishes itself as one of the leaders in biosimilars development. Valtropin will enter EU markets where Omnitrop may have already been launched; the latter has already been launched in Germany and an Austrian launch is imminent. However, the timing advantage of Omnitrop will be measured in terms of a few months. Novartis and its Sandoz unit are likely to spend heavily on promoting Omnitrop to doctors in order to deal with any initial resistance to a biosimilar human growth hormone and with safety concerns. Valtropin – when it is launched – is likely to benefit from this initial promotion of biosimilar human growth hormone and keep its sales and marketing costs down.
Both Valtropin and Sandoz' Omnitrope/Omnitrop are copies of U.S. Eli Lilly's Humatrope (somatropin) and will compete in the same US$1.882-billion market. Biopartners will have to match the price discount vis-à-vis the originator biotech drug offered by Sandoz, but the discount (20% in Germany at 34.52 euros (US$43.43) per milligram retail) is not particularly large. Discounts of 15-20% have been predicted for biosimilars given the high barriers to market entry (i.e., production challenges and difficulties in securing approval). A further price discount of 5% or so is possible, when the number of competitors in the human-growth hormones market increases, but price discounts are unlikely to reach the amounts available with regular generics (bioequivalent copies of chemical drugs).
To find out more about Biosimilars, please visit our Biosimilars Market Watch
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- European Union: 7 March 2006: Pressure on European Commission as EMEA Recommends Approval of Second Biosimilar
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