Sandoz receives approval for biosimilar filgrastim in Japan
Mar 24, 2014
Sandoz Filgrastim approved in all indications as the reference product
Sandoz becomes first company to secure approval for two biosimilars in Japan
Approval marks continued expansion of Sandoz’ biosimilar business
Munich, Germany, March 24, 2014 - Sandoz announced today that Sandoz Japan has received marketing authorization approval for its biosimilar filgrastim (Kyowa Hakko Kirin’s GRAN®). The product, which will be marketed as Filgrastim BS Injection 75µg/150µg/300µg Syringe “Sandoz”, is the second Sandoz biosimilar to be approved in Japan. The approval paves the way for this important oncology medicine to be made available to oncology patients in Japan.
Filgrastim is used with certain cancer patients to accelerate recovery of infection-fighting white blood cells after chemotherapy (prevention of neutropenia) and is also used to stimulate mobilization of hematopoietic stem cells for collection and transplantation. Sandoz Filgrastim is approved in Japan for the same range of indications as the reference product GRAN and offers patients comparable quality, safety and efficacy combined with potentially greater cost-effectiveness for the healthcare system.
"We are pleased to receive our second biosimilar approval in Japan," said Junichi Nakamichi, Country Head, Sandoz Japan. "This product has already been used in clinical practice in over 40 countries around the world under the brand name of Zarzio® and we look forward to making this product available to patients and physicians in Japan."
Zarzio is the number one biosimilar filgrastim globally and in 2013 it became the most prescribed Daily GCSF treatment in Europe ahead of originator products from Amgen and Chugai.
Sandoz is the only company with marketing authorization for more than one biosimilar medicine in the Japanese market. In 2009, the company’s human growth hormone Omnitrope® (Pfizer’s Genotropin®) became the first-ever biosimilar medicine to be approved and launched in Japan.
Sandoz is the global leader and pioneer in developing, manufacturing and commercializing biosimilars. Sandoz markets three biosimilar products, all of which are #1 in their respective categories globally. Sandoz’ biosimilars are collectively sold in over 50 countries and have generated over 100 million patient exposure days of experience. Sandoz has an industry-leading biosimilars pipeline with six molecules in the Phase III clinical trials/registration prep stage including biosimilar versions of leading biologics such as adalimumab (AbbVie’s Humira®), etanercept (Amgen’s Enbrel®) and rituximab (Roche’s Rituxan®/MabThera®).
The foregoing release contains forward-looking statements that can be identified by terminology such as “will,” “committed,” “should,” “aimed,” “can,” “could,” “look forward to,” or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Filgrastim BS Injection 75µg/150µg/300µg Syringe “Sandoz”, or regarding potential future revenues from Filgrastim BS Injection 75µg/150µg/300µg Syringe “Sandoz”. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Filgrastim BS Injection 75µg/150µg/300µg Syringe “Sandoz” to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Filgrastim BS Injection 75µg/150µg/300µg Syringe “Sandoz” will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Filgrastim BS Injection 75µg/150µg/300µg Syringe “Sandoz”could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; uncertainties regarding actual or potential legal proceedings, including, among others, intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling Filgrastim BS Injection 75µg/150µg/300µg Syringe “Sandoz”, and the uncertain outcome of any such litigation; the particular prescribing preferences of physicians and patients; competition in general; government, industry and general public pricing pressures; unexpected manufacturing difficulties or delays; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Sandoz is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees and its products are sold in more than 160 countries, offering a broad range of high-quality, affordable products that are no longer protected by patents. With USD 9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics, complemented by leading positions in the cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal therapeutic areas. Sandoz develops, produces, and markets these medicines, as well as active pharmaceutical and biotechnological substances. Nearly half of Sandoz's portfolio is in differentiated products, which are defined as products that are more difficult to scientifically develop and manufacture than standard generics.
In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has benefitted from strong growth of its acquisitions, which include Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).