Biosimilar Medicines Need Strong Regulation, IP Crucial For Innovation, Pharma Says

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Biosimilar medicines might prove to be a new reservoir for innovation for the pharmaceutical industry. However, the complexity of their manufacture needs a stringent regulatory framework, according to the industry.

Biosimilar medicines, according to the World Health Organization (which refers to them as “similar biotherapeutic products”), are products which are manufactured following the expiration of the patents or the data protection for the first major group of the originator’s biotherapeutic products.

During the16th International Conference on Drug Regulatory Authorities being held from 26-29 August in Rio de Janeiro, Brazil, a particular focus was given to biosimilars. Notably, a pre-conference concentrated on quality and safety of biosimilars for patients (IPW, Public Health, 26 August 2014).

Among the first group of biotherapeutic products that came on the market were insulin and human growth hormone, the WHO website says. “This is expected to contribute to increased access to these products at an affordable price.”

However, the WHO says, “a generic approach as applied to small-molecule pharmaceuticals is not appropriate for biological substances due to their complexity and the fact that clinical performance depends critically on the production process.”

Biosimilar medicines, unlike conventional medicines, are very complex, much larger molecules. According to a video by Amgen, conventional drugs can be manufactured following multiple methods, which allows the drugs to be manufactured by multiple companies once the patent expires. Biotherapeutics are manufactured through a challenging process and engineered through living cells and require a high degree of technicality.

“Because of their structural complexity, and impurity profile, biotherapeutic medicines may induce the formation of antibodies and trigger immune responses,” according to an International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) brochure [pdf]. “Small changes in the manufacture process can lead to changes in the final product composition.”

IFPMA to Countries: Regulate It

According to Janis Bernat, IFPMA association director for biotherapeutics and scientific affairs, “It is not that they [biotherapeutics/biosimilars] are better or more efficient, but they can in some instances provide more targeted treatments [than conventional medicines]. Biotherapeutic medicines can offer a different mode of treating diseases, an additional treatment option.”

“Biotherapeutic medicines, including biosimilars, are used to treat diseases like cancer, diabetes, some infectious diseases, some auto-immune diseases such as arthritis, and some heart diseases,” she told Intellectual Property Watch.

“Many countries are still in the process of getting their regulatory procedures/processes in place for the registration of biotherapeutic and/or biosimilar medicines,” she said, adding, “that is an issue right now.”

“There are some concerns for countries in the process of implementing regulatory procedures for biotherapeutic medicines as there could be some biotherapeutic medicines that may have been approved through pre-existing pathways, such as the generic pathway for traditional medicines,” she said.

“When a country is developing its new regulations for biotherapeutics and biosimilars, they also need to consider what should be done with the products that have been previously approved. There are quite a few of those products currently on the market and WHO is expected to look into this and provide guidance to countries on those previously approved products.” she added.

For example, she explained, “WHO recommends the comparison of a biosimilar candidate with the reference product. In the past, drugs on the market maybe have not been approved to the level now required for biosimilars, or against a reference product.”

A reference product is usually an innovator biotherapeutic product that has been approved with a full data package, including full clinical data, is well-characterised and has some history of use, she said. “When a biosimilar candidate is being developed, it is compared with the reference product.”

“The reason for a stringent regulatory framework is to protect the safety of patients and ensure the efficacy of medicines. Regulatory frameworks are applicable to all medicines as there is no differentiation between manufacturers. As countries develop their regulatory pathways and procedures for the approval of biotherapeutic and biosimilar medicines, this will allow for greater access,” she contended.

“For IFPMA is it really important that regulations are developed at the national level, in alignment with the guidance provided by WHO,” she said.

The Promise of Innovation and IP

“Although there are still development opportunities for conventional medicines, biotherapeutics do provide an opportunity for growth and innovation,” according to Bernat.” Scientific advances continue, providing new opportunities, such as personalised medicines. There are plenty of opportunities in this field for further developments.”

According to IFPMA [pdf], “Further research and development into biotherapeutic medicines will continue to expand opportunities to treat an ever increasing number of diseases, and intellectual property rights will remain a crucial incentive for such innovation.”

In 2008, the group said, “633 biotherapeutic medicines were under development, including 254 for cancer.” It takes an estimated investment of US$1.2 billion to develop a new medicine, they said, insisting that research and innovation into new therapeutics need strong intellectual property protection.

“A biosimilar manufacturer could acquire patent protection through the invention of process- or technology-related advancements,” according to Bernat. However, “these new processes or technological advancements may or may not be patentable; [for example] it would need to satisfy all the patentability criteria.”

The European Patent Office told Intellectual Property Watch that biosimilars are patentable in principle, like any other pharmaceutical composition. However, they might fail to meet the requirement for inventive step following Article 56 of the European Patent Convention. In individual cases, “there may be grounds for acknowledging inventive step,” the source said.

“The patent protection on many originator reference biotech products has expired already, and many more will expire over the next few years,” according to a European Generic Medicine Association document. “As a result most commentators expect a growing number of biosimilar products on the market in the not too distant future,”

Affordability Question

In a 26 August letter to the attention of Drug Regulatory Authorities gathered in Rio,
a group of non-governmental organisations warned against ” the exorbitant price of biotherapeutic products.”

According to the letter, “In 2007 the global market of biotherapeutics was around 100 billion USD. In 2012 it surpassed 170 billion and it is expected to reach 250 billion USD by 2020.”

Catherine Saez may be reached at

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