ANVISA Approves First Infliximab Biosimilar in Brazil

SAO PAULO, June 2, 2015 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), a global leader in biosimilars, today announced that its partner, Celltrion – a global biopharmaceutical company – has received approval from ANVISA – the National Health Surveillance Agency in Brazil – for Remsima (infliximab), the first biosimilar monoclonal antibody approved for use in Brazil. The medication will be marketed by Hospira. Hospira also markets and sells biosimilar infliximab in 26 European countries and in Canada under the brand name Inflectra. This important product has been approved in Brazil for the treatment of: rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn's disease in adults and children, fistulizing Crohn's disease (advanced), colitis and ulcerative rectocolitis.

Remsima is the first biological medication approved by Brazil's regulator, ANVISA, based on comparability. A comparability study is required because under ANVISA's Normative Resolution RDC 55/2010, biosimilarity must be proven by direct comparison with the reference biological drug (products must be compared in a single clinical trial and using the same procedures). The study provided evidence of similarity between Remsima and the reference biological product, Remicade™ (infliximab).  

"Biosimilars with comparative data of safety and efficacy are welcome by health professionals and also by the patients who use them. The effectiveness and safety of medications should be the foremost concern of those who manufacture, purchase and prescribe these drugs," said Valderilio Feijo Azevedo, M.D., a rheumatology specialist of the Brazilian Rheumatology Society and coordinator of the Brazilian and Latin American Forum for Biosimilars 2010-2014.

In a phase III trial involving 606 patients, Remsima achieved its main goal of treatment equivalence with Remicade. The trial showed that 73.4 percent of patients receiving Remsima achieved a 20 percent or better improvement in rheumatoid arthritis symptoms (based on American College of Rheumatology criteria) after 30 weeks of treatment, compared with 69.7 percent for Remicade.

During the same trial, 42.3 percent of patients receiving Remsima achieved a 50 percent or better improvement in rheumatoid arthritis symptoms (based on American College of Rheumatology criteria) after 30 weeks of treatment, compared with 40.6 percent for Remicade.  Remsima also presents a similar safety and tolerance profile to Remicade. 

"A robust package of comparative analyses involving Remsima and Remicade showing biosimilar infliximab's effectiveness and safety during rheumatoid arthritis treatment, as well as supporting data for ankylosing spondylitis, allowed us to extrapolate the data and gain approval from ANVISA to use the biosimilar in treatments for all approved indications of the reference product, without the need for additional clinical trials," said Sergio Teixeira, M.D., medical director for Hospira Brazil.

We are looking forward to offering patients in Brazil better access to high-quality, effective and more affordable treatment options that can also help alleviate some of Brazil's rising healthcare costs," continued Teixeira.

Remsima and Inflectra were approved by the European Medicines Agency (EMA) in 2013 and are currently available in most European countries. Celltrion submitted an application to ANVISA to approve Remsima and Hospira will market the product exclusively in Brazil. 

Hospira and South Korea-based Celltrion entered into a business cooperation agreement in 2009 for eight biosimilar products, including biosimilar infliximab. Hospira and Celltrion recently expanded their biosimilars partnership, which now provides Hospira with exclusive rights to distribute biosimilar infliximab in many major markets, including Brazil, Mexico, United States, as well as in many European countries and in Canada.  Under this agreement, Hospira will assume responsibility for sales and marketing for this important medication in Brazil, under the brand name, Remsima.

With 12 biosimilars in its pipeline, Hospira has one of the largest biosimilar portfolios in the industry. The company has more than seven years of experience with biosimilars and has supplied more than 10 million doses of biosimilar medication to patients worldwide. 

About Remsima

Remsima (infliximab) is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNF alpha but not to lymphotoxin α (TNF beta). Remsima is indicated for: rheumatoid arthritis, adult Crohn's disease, pediatric Crohn's disease, fistulizing Crohn's disease, colitis, ulcerative rectocolitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

About Hospira

Hospira, Inc. is a global leader in biosimilars and the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill. Learn more at www.hospira.com.br.

About Celltrion

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion previously received EMA approval for Remsima which is the world's first biosimilar mAb to receive approval from a regulatory agency in a developed country.

-- A Caution Concerning Forward-Looking Statements --

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally relate to future events or Hospira's future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these words or other similar terms or expressions that concern Hospira's expectations, strategy, plans or intentions. Forward-looking statements in this press release include the outcome of naming decisions related to biosimilars, the pace of growth of the U.S. biosimilars market and the action of competitors. Hospira's expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Actual results may differ materially from those indicated by these forward-looking statements as a result of various factors, including, without limitation, challenges inherent in creating and developing compounds and product candidates and economic, competitive, governmental, regulatory, legal, supply and other factors. Information on these and additional risks affecting Hospira's business and operating results are more fully discussed in the section entitled "Risk Factors" in the company's most recently filed annual report on Form 10-K and any subsequently filed quarterly report on Form 10-Q. The forward-looking statements in this press release are based on information available as of the date hereof, and Hospira disclaims any obligation to update any forward-looking statement, except as required by law.

SOURCE Hospira, Inc.

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