21 Dec Who’s leading the Biosimilar race?/谁在生物仿制药的竞争中处于领先地位?
World pharmaceutical companies scramble to be number one
The medical profession is established upon the precept of building cures for illnesses and diseases. Specifically, pharmaceutical companies and bio-engineers have worked tediously to make treatments available to the common man. And while there have been tremendous hurtles overcome in generic medications, the Biosimilar drugs have not seen much integration into the public market until recently when the FDA allowed an immune boosting drug by Amgen to be introduced to the market. As such, the global pharmaceutical companies are in a race to develop and introduce similar drugs into the pharmaceutical market.
Amgen may have the first FDA approved drug but is it really the forerunner?
Granted, emerging into the market with an FDA approval is typically considered to be the top advancement of a pharmaceutical company. And where it is true that the American based company has been the first to get the FDA’s approval for a biological drug, the company until now has stayed a step behind Celltrion (a South Korean Company).
Amgen’s immersion into the public sector has not arrived without opposition. Sandoz, a pharmaceutical company based out of Germany but claims to be part of the Swedish company Novartis, is challenging whether or not the legal requirements of filgrastim (Neupogen) was met. At the same time, the company is seeking their own approval of pegfilgrastim from the FDA. Celltrion has also submitted a biosimilar drug for FDA approval called Remicade.
Where it may be true that the California based company is currently in the lead, if the legality of the FDA’s approval proves to not meet the requirements (as is the hope of the other pharmaceuticals) then it can be predicted that the South Korean Company Celltrion will again be in the lead. Even if the FDA approval stands, if Remicade is introduced to the US market the pharmaceutical company is very apt to become the forerunner in the biosimilar race again.
Who is trailing behind in the race?
Currently, India has fallen way behind in the biosimilar race. With only three companies working on biosimilars the country may find themselves lacking a piece of the expected $15 billion dollar prize. True, the Indian market has partnered with Novatris which is one of the leading contenders for the biosimilars race, but Biocon Ltd, Dr. Reddy’s Laboratories Ltd, and Intas Pharmaceuticals Ltd. have dropped the ball in the development process.
Teva Pharmaceutical Industries Ltd. (Israel) and Lonza (Switzerland) have abandoned their joint venue biosimilars project. It does not seem that either are completely abandoning biosimilars. However, as the JV has died, the companies may find that developing a marketable new product may come a bit too late in the race. Additionally, any introduction of any biosimilar product resembling the JV would understandably be met with opposition from the other party.
How does the biosimilar race affect the general public?
The biosimilar race has proven to be quite aggressive. This is quite expected as the profits expected from the sales are over $15 billion. As such, the pharmaceutical companies have rigorously raised the bar for the quality of product. Where this may been seen as shooting themselves in the foot (as the more strenuous the stipulations the harder it is to develop), the public benefits from a drug that is lower in cost but higher in performance.
Additionally, companies which are developing biosimilar drugs will try to maximize the market. This will result in several different varieties of the biosimilar medications being offered to the public. Currently, Rheumatiod arthritis and white blood cell regeneration are at the forefront of this race. Yet, with the FDAs approval of the US drug, it is quite likely that other biogenetic similar will be constructed both by Amgen as well as the other lead contenders in a hope to increase their brand awareness and profits.
Who should we be watching?
Amgen, Celltrion, and Novartis are the companies to watch. These three biosimilar developers have long been in the front of the race. It would not be surprising to see Celltrion jump into the lead as they have 3 markets for their Remicade (the US, Europe, and local). Novartis has several partnerships and sub-companies globally which may help to increase their chances of jumping into the lead. As for now, Amgen leads the pack. It will be interesting to see how the race advances in the next year, especially as healthcare, pharmaceuticals, and drug developments come to the political arena.
目前，印度在这场生物仿制药的竞争中成为了落后者。该国只有三家公司致力于生物仿制药品的开发，而且可能会发现自己并没有获得价值150亿美元的奖金。诚然,印度市场已经与Novatris公司展开密切合作，后者是一家仿生物药品行业中的主要竞争者之一,但是Biocon有限公司, Dr. Reddy’s Laboratories有限公司和Intas Pharmaceuticals有限公司已经在药物开发过程中犯了很多错误。
Teva Pharmaceutical Industries有限公司(以色列)和Lonza公司(瑞士)已经放弃了他们的联合生物仿制药研究项目。但是两者并没有完全放弃生物仿制药的研究。然而随着合资企业的结束，这些公司可能会发现，现在开发出适合市场的新产品可能有点太晚了。此外，类似合资企业引进的任何生物仿制药往往会遭到来自另一方的反对。