Japan's Ministry of Health, Labour and Welfare has approved 367 generic products for inclusion on the National Health Insurance price listings in December. Novartis (Switzerland)'s generic subsidiary Sandoz was the only firm to gain approval for a generic of Japan's scandal-plagued but top-selling hypertension treatment Diovan (valsartan); other significant approvals went to versions of Leuplin (leuprorelin), Livalo (pitavastatin), and Glivec (imatinib).
IHS Global Insight perspective | |
Significance | The Ministry of Health, Labour and Welfare has released the list of companies with approved generics for National Health Insurance listing in December, with the most significant drugs included on the list including Diovan (valsartan), Leuplin (leuprorelin), Livalo (pitavastatin), and Glivec (imatinib). |
Implications | If Sandoz goes ahead with the launch of its Diovan version in December, it would mark the first time an authorised generic has been launched in Japan ahead of rivals, and would have six months exclusivity to soften the loss of patent protection. |
Outlook | Sandoz is likely to consider the market conditions for Diovan prior to launch, in light of reaction to recent allegations of data falsification during post-marketing trials of the drug. |
Japan's Ministry of Health, Labour and Welfare (MHLW) on 15 August released the list of marketing approvals for the next National Health Insurance (NHI) generic drug price listing in December, as reported by Pharma Japan. A total of 367 products gained approval, with approved companies required to prove production capabilities to the MHLW prior to formal listing.
Prominent approvals highlighted by the source include:
- Diovan (valsartan): Novartis (Switzerland)'s hypertension drug saw only one approval, to the firm's own generic unit Sandoz.
- Leuplin (leuprorelin): Takeda (Japan)'s luteinising hormone-releasing hormone, used as a cancer treatment, saw approvals for ASKA Pharmaceutical and Nipro Pharma.
- Livalo (pitavastatin): Kowa (Japan)'s hyperlipidaemia treatment saw 73 products from 30 companies approved.
- Glivec (imatinib), Novartis (Switzerland)'s cancer drug: five products from five firms.
- Valtrex (valacyclovir): GlaxoSmithKline (UK)'s anti-viral treatment saw approvals for 35 generic products from 31 companies.
- Zithroman (azithromycin), Pfizer (US)'s antibiotic: 36 products from 19 firms.
- Approvals for generic formulations not available for original drugs: orally disintegrating tablets of Lipitor (atorvastatin; Pfizer/Astellas, US/Japan) and dry syrups of Allegra (fexofenadine; Sanofi, France).
- Aricept (donepezil), Eisai (Japan)'s Alzheimer's disease drug: 62 products from 32 companies approved for 10mg versions.
- Heliobacter pylori (H. pylori) generic eradication therapies also approved.
Towa Pharmaceutical (Japan) topped the list in terms of most approvals with 25 products, followed by Nichi-Iko (Japan) with 18, Daiko Pharmaceutical (Japan) with 16, Shiono Chemical (Japan) with 15, Sawai Pharmaceutical (Japan) with 14, and Teva Pharma Japan (Israel) with 13.
Outlook and implications
The approval for Sandoz's authorised generic of Diovan is potentially the most significant on the list. The drug was Japan's second top-seller during 2012, with JPY108.3 billion (USD1.1 billion) in sales. If Sandoz goes ahead with the launch it would be the first time that an authorised generic has been launched in Japan prior to rivals. The drug would have six months of exclusivity prior to other rivals' versions reaching the market no earlier than June 2014, with the September 2013 patent expiry not coming early enough to allow firms to file for the December 2013 listing. Novartis/Sandoz will be likely to consider the ongoing controversies in Japan regarding alleged data manipulation during post-marketing trials of Diovan, with some effect on sales of Diovan likely as a result, but the firm has positioned itself quickly to potentially soften the impact of generic competition (see Japan: 31 July 2013: Novartis's Diovan woes continue in Japan with MHLW investigation, sales difficulties).
Nichi-Iko was the first firm to launch an authorised generic in Japan – a version of Sanofi's Allegra (fexofenadine) – in June this year, but that launch took place only after two other generic versions had reached the market (see Japan: 29 April 2013: Sanofi Nichi-Iko JV's launch of Allegra in June will be Japan's first authorised generic). Similarly, Kowa partner Teika Pharmaceutical (Japan) secured approval for an authorised Livalo generic for the previous June listings, but did not go ahead with the launch, and now potentially faces competition from 30 other companies. Livalo saw sales of JPY31.9 billion during 2012.
ASKA's approval for Leuplin is not an authorised generic version, despite the firm's close relationship with originator firm Takeda, which markets ASKA's products in Japan and has a share of the ownership. ASKA and Nipro will be fighting it out for what was a JPY66-billion market last year. Glivec is another major approval, with NHI sales of JPY38.3 billion during 2012.
Related article
- Japan: 2 July 2013: Japan's new NHI generics listings include first AG of Allegra plus Prograf, TS-1