Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts from the ‘Biosimilars’ category

At the 2013 Annual Meeting of the American Society of Clinical Oncology in Chicago this past weekend, my impression of one of the most popular posters in terms of how fast the poster handouts disappeared (all 100 went in 7 minutes) was a phase 1 trial comparing PF-05280014, a potential biosimilar to trastuzumab (Herceptin) in healthy volunteers (ASCO 2013 Abstract No: 612)

Herceptin is used for the treatment of HER2+ breast cancer, and with global sales of over $5 billion, represents a major source of sales to Roche. However, Roche’s patent for Herceptin is expected to expire in 2014 in the UK, 2015 in Europe and 2019 in the United States, providing an opportunity for other companies to take a significant share of this market away from them.

Roche have long focused on life cycle management with strong patent defense built in to their long term strategic plans. In this case, their approach has been to launch new breast cancer products in the HER2 segment such as pertuzumab (Perjeta), for use in combination with Herceptin, and Kadycla (T-DM1) for advanced breast cancer patients who become treatment resistant to Herceptin. Trials are ongoing in the front-line setting with the goal of replacing Herceptin.

Several companies, including Amgen and Novartis, are looking to develop a biosimilar to Herceptin for the treatment of HER2+ breast cancer, and it now looks like Pfizer is in the race too. A biosimilar product is not a generic “copycat” i.e. a copy of a small molecule chemically synthesized to provide equivalent efficacy. Instead, a biosimilar is a copy of a biological compound such as an antibody or protein produced by living organisms intended to be equivalent to the original product. In general, monoclonal antibodies are much more difficult and complex to re-engineer than a pill or TKI.  This means that the main competitors in the biosimilar market are more likely to be generic offshoots of big Pharma rather than Indian generic companies, since they possess the technology and resources to engineer monoclonal antibodies.

There’s a lot of debate over biosimilars and whether they are truly identical. In the United States, the Biologics Price Competition and Innovation Act (BPCI) contained within the Affordable Care Act provided a regulatory route for biosimilars to be approved by the FDA, so long as they could be clinically shown to be “highly similar.”  Once approved, biosimilars are expected to be interchangeable, i.e. substituted for the original product with the expectation that lower drug prices will be the result. This represents a major competitive threat to Roche’s Herceptin HER2 franchise.

Interestingly at ASCO, Pfizer did not provide a QR code that linked to a PDF copy of their PF-05280014 poster, unlike most of their other posters at the meeting. I expect we will be hearing a lot more about biosimilars in the not too distant future, and the potential importance of this was highlighted by the intense popularity of Pfizer’s poster at the meeting.

Viewers of the ASCO 2013 preview video from Sally Church, PhD will have noted that PF-05280014 was one of her key breast cancer abstracts to watch out. If you haven’t already done so, here’s a link to the Pharma Strategy Blog ASCO 2013 Preview Video (free via sign-up) that is well worth watching.

Update June 5, 2013 5pm.  This post was not intended to be a comprehensive analysis of the biosimilar market and all the players (you have to pay me for that). However, Josh Berlin @BioPharmaJosh kindly pointed out on Twitter that the controversial Korean company Celltrion have filed for approval of their Herceptin biosimilar in Korea. This represents a competitive threat to Roche’s Asian market, and could give other companies a run for their money if they are first to market and file for approval elsewhere.


The decision expected this Thursday by the Supreme Court of the United States on the constitutionality of the Patient Protection and Affordable Care Act (PPACA) may impact the development and approval of biosimilars.

US Capitol Photo Credit Pieter DroppertPart of the PPACA signed into law by President Obama on March 23, 2010 was the Biologics Price Competition & Innovation Act (BPCI).

This amended the Public Health Service Act (PHS) to create a pathway under section 351(k) for the licensing of biological products that are “interchangeable” or “biosimilar” to an FDA-licensed product.

In addition, to a licensing pathway, the regulatory framework introduced “exclusivity” periods that prevented approval of a 351(k) application until 12 years after the first license of the reference product. I doubt very much that Congress will want to have to negotiate exclusivity provisions again.

I am not a regulatory expert, but my understanding is that if the Court declares the PPACA unconstitutional in its entirety, the BPCI would be lost too.

At the risk of venturing an opinion, I don’t think the Court will want to cause collateral damage to uncontroversial parts of the PPACA such as the BPCI, but it is something to watch out for this Thursday.

Many commentators think it likely the Court will uphold certain parts of the PPACA and invalidate other provisions. This was the approach the Court followed in a decision earlier this week on Arizona Immigration Law (Arizona v. United States).

However, until a decision is published by the Court, nobody knows.  Thursday is set to be a landmark day whatever the Court decides.

Update June 28, 2012

In a 5:4 opinion, the Supreme Court has upheld several provisions of the Patient Protection and Affordable Care Act (PPACA). The Court did not rule the PPACA unconstitutional in its entirety which was the only way the biosimilars provisions would have been lost. Therefore, from a biosimilar regulatory perspective, nothing has changed as a result of today’s decision – the exclusivity and approval pathway are maintained. This is good news for the biotechnology industry.

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I am excited to be attending, for the first time, the Biotechnology Industry Organization (BIO) international convention that takes place in Washington DC in just over a week’s time from Monday June 27 to Thursday, June 30th.

This meeting has something for everyone interested in the biotechnology industry whether it be deal making, partnering, licensing, drug discovery or personalized medicine. There are 16 specialized tracks where industry experts provide insight and best practices.

In addition, there are numerous networking and social events plus an exhibit hall that showcases the world’s biotech regions and how they are promoting innovation.

At meetings where there are parallel sessions, I apply “the law of two feet” (thanks to Podcamp for this) that says if you are not getting what you want from the session, it’s OK to walk out and go to another one.

My top 10 sessions at BIO reflect my personal interests in innovation, science and new product development:

Tuesday June 28

  • How will we afford Personalized Medicines?
  • The Biomarkers Consortium: Facilitating the Development and Qualification of Biological Markers
  • Personalized Oncology: The emergence of Personalized Medicine Strategies in Oncology Clinical Development and Deal Making
  • Navigating the New Law on Licensing Biosimilars

Wednesday June 29

  • Lessons from a Mature Public-Private Partnership. The Alzheimer’s Disease Neuroimaging Initiative
  • Emerging Markets. The Future of Growth for Biologics?
  • The Role of Imaging Biomarkers in Early Phase CNS Drug Development
  • The Promise of MicroRNA-based Therapeutics in Cancer

Thursday Jun 30

  • After the Fall. Venture Capital and the Biotech Funding Landscape
  • Regulatory Issues for Tissue Engineered Products

If you have plans to be at BIO 2011 do say hello after one of the sessions or receptions. You can reach me at the meeting via twitter (@3NT).  See you in DC!

Follow 3NT on Twitter

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The race to bring a biosimilar version of Sanofi-Aventis’ low molecular weight heparin, Lovenox® (enoxaparin sodium), to market had three players, Momenta Pharmaceuticals in partnership with Sandoz, Amphastar Pharmaceuticals and Teva.

The winner was Momenta/Sandoz who (as mentioned in a previous post) recorded $292 million of sales in 69 days post launch.   As reported by the Wall Street Journal, Amphastar are now suing the FDA alleging the agency acted arbitrarily in delaying its imports of raw heparin.  There certainly seems to be no love lost between Amphastar and the FDA, who earlier this year alleged a conflict of interest between Janet Woodcock, the Director for the Center for Drug Evaluation and Research (CDER) and Momenta as a result of the collaboration that identified the contaminant in chinese heparin that killed patients in 2008.  Following an FDA investigation, Woodcook was cleared of any conflict of interest but announced she would not participate in the biosimilar approval decision.

In the run up to the approval, the FDA visited the manufacturing facilities for all three companies. Afterwards the status of the Amphastar application became less certain. Unlike Amphastar, both Teva and Sandoz had prior experience of obtaining FDA approval for biosimilar products.

Given the amount of money at stake, its easy to see why Amphastar are unhappy. However, alleging conflicts of interest and arbitrary practices does not exactly win friends and influence people.  I am sure the FDA have a credible factual basis for their decision making, in which case Amphastar is unlikely to get anywhere, other than generate negative publicity for themselves.  Others may differ in that opinion, and if you want to read a legal analysis of the Amphastar complaint, the FDA Law Blog’s post is worth reading. It also has a link to the actual complaint filed.

The more interesting question is when is the FDA going to approve the Teva biosimilar version of Lovenox®? When this happens, Sandoz’s first mover advantage will come to an end and further price erosion is likely. According to Reuters, analysts predict this may happen before the end of 2010.

Update: Amphastar gains FDA approval for generic Lovenox

As reported by Ed Silverman on Pharmalot (September 19, 2011), “Amphastar Pharmaceuticals has finally won approval to sell a generic version of Lovenox


The news, reported by Bloomberg, last week that generic companies may be subject to stricter FDA standards in order to show therapeutic equivalence is good news for the biotech industry and consumers.

Generic companies have a pretty easy ride in obtaining product approval, and I’ve long been convinced that the formulation of a brand, and what makes it work can include the so called inactive ingredients and how it is put together.   I know of many people who have experienced side effects with generics that they don’t have with the branded product.

For this reason, branded generics from the original manufacturer have the ability to retain some market share in the face of generic competition.  Sandoz, the generic arm of Novartis uses this strategy to good effect with many mature products.   However, if companies instead want to try and maintain a premium priced brand and not adapt to the entry of generics, then they will find their market share erodes extremely fast. Not only is brand market erosion fast with generic drugs, but with biosimilars too.

As reported by Reuters, sales of generic enoxaparin sodium injection, Momenta’s copy of Sanofi’s anti-thrombotic, low molecular weight, heparin sold as “Lovenox” were $292million in the third quarter of 2010. Sandoz markets enoxaparin on behalf of Momenta. They launched the product on July 23, and achieved  $292 million of sales in 69 days. With annual sales forecast to be over $1billion, the biosimilar will be a blockbuster and make a significant dent in the $2.9 billion sales of Lovenox in 2009.

The Boston Business Journal reports that Sandoz/Momenta have captured 60% market share already, which is not good news for Sanofi-Aventis and may explain their desire to make acquisitions such as Genzyme to make up for this loss.

Biosimilars that are fully substitutable for the original product, look likely to erode brands extremely fast.  Momenta’s success is good for the biotechnology industry and highlights the future market opportunity from development of biosimilars.

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