Sandoz Wins Biosimilar Filing Race

After months of speculation about prospects for biosimilar development in the United States, Novartis announced on July 24 that FDA has accepted Sandoz’ biologics license application (BLA) for a similar version of Amgen’s Neupogen (filgrastim). Assuming FDA approval within a year, this action sets the stage for testing whether and how biosimilars will gain acceptance in the US healthcare market, and the impact these products will have on new drug development and product pricing and marketing.

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Global Biosimilars Market to Reach $2.445 Billion in 2013

VLUU L110  / Samsung L110The global market for biosimilar drugs has been forecasted to be worth $2.445 billion this year, according to a new report by British market research specialist Visiongain. The growth represents a 20% increase from last year and accounts for approximately 2% of the overall biologics market. Moreover, the global biosimilars market is expected to experience a steady growth over the next 10 years, driven by worldwide launches of such products, particularly in the EU and US. Read more »

Era of the Biosimilar: The Inevitable Change

Stephanie Sutton Pharm Tech EuropeBiosimilars. They bring cheap prices to patients and healthcare payers, but for biopharmaceutical companies, such products impact the sales of innovative biopharmaceuticals. The pros and cons of biosimilars have been under discussion for some time in the bio/pharma industry, but the debate is now gaining increased momentum as the US moves closer to solid guidance concerning the development of biosimilars. Read more »

Key Healthcare Challenges for Obama, Congress

Jill Wechsler Washington EditorEfforts to repeal the Affordable Care Act (ACA) died on election day, as President Barack Obama won a second term in the White House and the Democrats maintained control of the Senate. House Republicans will continue to challenge various provisions in the health care legislation, but key provisions for pharmaceutical companies, such as rebates on drugs for seniors in the Part D coverage gap and authorization for biosimilars, are unlikely to change. Read more »

Biopharma Industry Set to See New Technologies and New Therapies

Stephanie Sutton Pharm Tech EuropeA new report has forecast that the global biopharmaceutical market will be worth more than $320 billion by 2020, up from just $138 billion in 2011. According to global business intelligence firm GBI Research, annual revenues for biopharmaceuticals have been rising year on year since 2001. In 2011, biopharmaceuticals accounted for 15.6% of the total pharmaceutical market. Read more »

Generic Drug and Biosimilar User Fees Gain Traction

Patricia Van Arnum PharmTech editor FDA issued last week its recommendations for three user-fee programs: the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and new user-fee programs for human generic drugs and biosimilar biological products. The recommendations were transmitted to Congress, which will evaluate the recommendations. Read more »

Live at CPhI: And so it begins!

Rich WhitworthThe day started with a 5 o’clock alarm call and me feeling remarkably fresh to begin my journey to Frankfurt for this year’s CPhI Worldwide event. Unfortunately, the idea of a smooth journey was thwarted fairly quickly with the news at Crewe that the 06:33 train to Manchester airport was canceled. Bad start. Read more »

FDA Follows EMA toward Follow-On Biologics

Erik Greb PharmTech editorDuring this cost-conscious time, many patients and other healthcare payors are opting for generic versions of branded pharmaceuticals. Biopharmaceuticals have claimed a place in the spotlight, but the US currently has no regulatory pathway for biosimilars. That could change after FDA releases its final guidance on follow-on biologics later this year. Read more »

Branded Medicine Use In Decline

Stephanie Sutton Pharm Tech EuropeNew analysis from IMS Health has painted a gloomy picture for branded medicines for the next five years as patent expiries and national policy changes take their toll. Spending for branded products in developed markets will remain at the same level in 2015 as in 2010; however, the market share for branded medicines, which fell from 70% in 2005 to 64% in 2010, is expected to decline to 53% by 2015. Read more »

User Fees: Another Step in the US Pathway for Biosimilars

Patricia Van Arnum PharmTech editor FDA issued this week a notice in the May 10th Federal Register in which the agency is requesting input from stakeholders and the public on a proposed user-free program for biosimilar and interchangeable biological product (i.e., Sec. 351 (k)) applications. The call for input on biosimilar user fees, a mechanism to fund regulatory review, is another step toward the development of a US regulatory pathway for biosimilars. Read more »

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