Who’s leading the Biosimilar race?/谁在生物仿制药的竞争中处于领先地位?

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.

世界制药公司都在争相成为世界第一

医疗职业是根据治疗疾病和传染病的规则来建立的。具体地说,制药公司和生物工程师每天都在忙于繁琐的工作,来为普通人提供各种治疗药物。虽然仿制药物已经出现了突飞猛进的发展,但是生物仿制药并没有真正地进入公众市场,直到最近FDA(美国食品药品监督管理局)允许Amgen公司的免疫增强药物进入市场。因此,全球的制药公司都在竞相开发和推出了各种类似的药物。

Amgen可能是第一家获得FDA批准的公司,但它是真正的先驱吗?

当然,获得FDA的批准并进入市场通常被认为是顶级制药公司的重大突破。虽然这家美国公司是第一家获得FDA批准的生物药物公司,但是该公司直到现在一直落后于Celltrion(韩国公司)。

Amgen公司的产品进入公共部门遭遇了很多的反对意见。德国Sandoz制药公司声称是瑞典Novartis公司的一部分,该公司正在挑战是否满足白细胞生成素(Neupogen)的法律规定。与此同时,该公司正在从FDA寻求自己的聚乙二醇非格司亭(Pegfilgrastim)批准。Celltrion公司也给FDA提交了一份名为Remicade的生物仿制药物。

这家来自加州的公司目前处于竞争中的领先地位可能是真的,如果FDA批准被证明不符合相关的要求(这也是其它药物开发的希望),那么可以预测,这家韩国公司Celltrion将再次处于领先地位。即使FDA批准成立,如果Remicade一旦进入美国市场,那么该制药公司也很容易再次成为生物仿制药竞争中的领先者。

在这场竞争中,谁成为了落后者呢?

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。

生物仿制药的竞争会对普通大众造成什么影响?

生物仿制药竞争已被证明具有非常明显的积极作用。预期的销售利润额超过了150亿美元。因此,制药公司已经严格提升了产品的质量。这可能被视为搬起石头砸自己的脚(因为规定越难,研究开发就越艰苦),但是普通大众就可以获得更低成本,但高质量的药物。

此外,这些公司将试图进一步扩张生物仿制药的市场。这将导致这些制药公司将为普通大众提供很多不同种类的生物仿制药物。目前,Rheumatiod关节炎和白血细胞再生是这场竞争的前沿课题。然而,随着FDA批准美国药物,Amgen和其他的主要竞争者很可能会开发其它类似的生物项目,以提高他们的品牌知名度和利润。

我们应该关注谁?

Amgen公司, Celltrion公司和Novartis公司应该是我们关注的公司。这三家生物仿制药开发公司一直在竞争中处于领先地位。而且,Celltrion成为一家领先的公司一点也不令人惊讶。因为他们的Remicade拥有3大市场(美国、欧洲和当地市场)。Novartis在全球范围内有几个合作伙伴和分公司,这可能有助于增加他们的竞争优势。至于现在,Amgen公司在竞争中独占鳌头。我们非常期待明年竞争的结果,尤其是从医疗、药品和药物开发到政治领域的结果。