Learn English Grammar From A–Z
- Based on European experience, Amgen could sell its biosimilar at a price discount of 15-20 percent versus Neupogen upon launch.
- Since these agents are not considered bioequivalent, the pharmacy cannot substitute a biosimilar for the branded version.
- So far, the only country where a Celltrion-made biosimilar is on the market is South Korea.
- FDA has not approved tbo-filgrastim as a biosimilar to Neupogen (filgrastim).
- I can add another example, the cost of developing a biosimilar that costs around 30 million.
- Presently the company is developing a biosimilar of the antibody, a drug with dramatic therapeutic effects for rheumatoid arthritis.
- The drug is being developed as a biosimilar to Herceptin.
- The first-ever approved biosimilar, Omnitrope (somatropin), arrived on the European market in 2006.
- Considerable investment is also needed to produce a biosimilar and bring it to market.
- The process to develop a biosimilar is more complex than that of developing a generic copy of a chemical-based compound.
- Patients will either get the biosimilar or actual Rituxan.
- We have no idea at this point whether this biosimilar will prove efficacious.
- Generic drugmakers are pushing into the field of biosimilars as global pharmaceutical companies face the loss of patent protection on many established drugs.
- Now it's true that some patent expirations expected in the 2011-2013 timeframe have been pushed out, and it's also true that biosimilars could be a sizable opportunity.
- The attractiveness of biosimilars, regardless of the product, is you'll always have limited competition because of the complexity and the investments required to make such medicines.
- Expertise in injectables could also help when the market for biosimilars, or copycat biotechnology drugs, opens up.
- The complexity of biosimilars has led to a drawn-out process and more questions posed by the industry.
- The United States wants to learn more about how other TPP countries "address the issue of biologics and biosimilars before proposing any specific provisions," she said.
- Biosimilars will have to be advertised and explained.
- Also discussed in detail are success factors for the emerging biosimilar industry and the regulatory environment in emerging markets with respect to biosimilars.