|The AmeriKat successfully keeping|
herself awake yesterday morning
Masahisa Yamaguchi (Chugai Pharmaceutical Co, Japan) provided a very concise and helpful summary of the biosimilars landscape. Masahisa explained that unlike small molecule drugs, it is impossible to produce exact copies of reference biological drugs. As such, the regulatory pathway to approval of such drugs is crucial. However, the global regulatory position is mixed. In Japan there is only one single guideline published in 2009 in relation to all types of biosimilars. In the US there are four draft guidelines including the latest one, published in 2014, entitled Clinical Pharmacology Data to support Demonstration of Biosimilarity to a reference Product. However, these are all draft guidelines. In Europe, a general guideline has been published entitled "Similar biological medicinal products". There are also product specific guidelines in Europe making Europe's regulatory landscape a little bit more user-friendly.
Masahisa explained that the major feature that these three systems have in common are the requirements of post-marketing surveillance studies and risk management plans. The big difference between the three systems is that in naming. In Japan a different non-proprietary and brand name is required to be distinguishable from the reference drug. In Europe the biosimilar adopts the same non-proprietary name as its reference product. In Australia they use a different non-proprietary name. In Japan, there is a three-part naming process. The divergence in approach has led the World Health Organization to develop its own recommendations - the use of the same non-proprietary name as the reference product plus a unique suffix. Generally, innovators argue that a different non-proprietary name should be required, while generics oppose such an argument. The main point in dispute, Masahisa explained, really turned on what is better for prescribers and patients. In his view, both arguments have merit, but for now the only certainty was that the different regulatory authorities had different opinions on the issue.
|AIPPI's Pharma 2 lineup for yesterday morning|
Looking to the future, Masahisa explained that the projected total sales of biologics to 2020 shows rapid growth. One of the most important and strong areas of growth is the monoclonal antibody field. This will be the next target for biosimilars, he concluded, but it requires significant investment.
Agnes Klein (Health Canada) was next up to explain the regulatory framework for drugs and biologics in Canada under the Food and Drugs Act. Following a technical sprint through the Canadian regime for biosimilar approval, Agnes described some key pointers for framing the studies that Canada Health look at when examining biosimilar applications. Such factors included the preference of equivalence trial data over non-inferiority trial data, studies that are conducted using clinically relevant endpoints to detect potential differences (which could be different from the innovator's original study) and for pivotal trials, duration, route of administration and dosage ranges should be similar. On the final point, Agnes stated that it was very unlikely that extrapolation of a different route or dosage would be permissible if there was no sufficient pharmacokinetic or pharmacodynamic data to support such extrapolation.
|Health Canada says "no"|
to automatic biosimilar
Agnes concluded by explaining that Canada Health does not support automatic substitution of a biosimilar for a reference drug, but that biosimilars "are safe and effective as guidelines are sufficiently robust to ensure safety and efficacy.
Prior to introducing the final panelist for the morning, the moderator Mary Padbury (Ashurst, Australia) cited a comment made by to provide some context for the current slow growth rate of biosimilars in the global market. Jimenez stated that although there will not be a big difference in the rate of growth of biosimilars for the next 2-3 years, there will be an inflection point in 2016-2019 when it is anticipated there will be big biosimilar launches. By 2020, we are likely to see a big impact in the biosimilar market.
|Is the Hospira v Genentech case just|
the first of many biosimilar cases
to come before the English Court?
Without any litigation in this space, it is difficult to predict whether the courts will react similarly to issues raised in biosimilar litigation as they do to those raised in standard small molecule litigation. A significant issue that Dominic raised related to the granting of interim and permanent injunctions. In the classic case the test for an interim injunction under American Cyanamid asks whether there is a serious question to be tried, whether damages would be an adequate remedy and where the balance of convenience lies. The launch of generics pre-patent expiry is a substantial threat to innovators given the dramatic price spiral following the first launch (see commentary in SmithKline Beecham v Apotex). The normal course of conduct is that the first generic prepares for launch, ends up challenging the patent(s), litigation ensues and depending on the outcome all the other generics with market approval pile in. The price of the innovator product reduces dramatically and its market share can reduce significantly. In such circumstances irreparable harm is straightforward as the price will never recover and it is therefore relatively easy to obtain an interim injunction from the English court.
|What does the future of biosimilar|
litigation hold? Do we have
some idea or is it into
the great unknown?
So what is the take-home point from this session? With a current diverse regulatory landscape and small market penetration, we are still few years off from reaching the precipice of the next big frontier in patent litigation. It probably won't be until the AIPPI Congress in Cancun, Mexico in 2018 when we really start seeing how the regulators and courts will react to this current great unknown.