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Manufacture Biosimilars

Why Share Your Biosimilars Cake?

With patents expiring on many established big biologic drugs, biosimilars have become increasingly tantalizing opportunities for manufacturers over the past 10 years. The first wave of biosimilars arrived in Europe in 2006 and 21 market approvals related to 14 molecules followed. Biosimilars have taken longer to emerge in North America – the first biosimilar reached the market in 2015, and only a few others have been approved since then.

Now, a second biosimilars wave – mostly related to monoclonal antibodies – is hitting, and drug makers worldwide are racing to launch these molecules. But biosimilars are not an easy business to break into and there are significant challenges. First, the manufacturer must develop a process to produce a protein that is fully comparable to the originator; second, they need to dramatically reduce the cost of goods to be the most competitive on the market; and third, they need to strategically position their products in relation to the number of potential competitor biosimilars in development.

Comparability is a key technical challenge, as the sequence of the protein is not the only attribute to consider. Many post-translational modifications, such as glycosylation, are directly related to pharmacological activity so the upstream process has to be developed with this in mind. As a consequence, analytics are a key factor of success at the very early stage of process development. Moreover, the cell line, media and feed have to be selected with attention not only to this first challenge of comparability, but also to the second challenge of cost of goods. These factors – cell line, media, and feed – directly drive productivity because of their correlation to the product’s titer. And when it comes to the market, titer is ultimately the only “justice of the peace” – indeed the only leverage one has in such a competitive landscape is the price of the product, and winners are naturally those who are able to preserve margins. Paradoxically, however, post-translational modifications can be altered when the titer is increased, mainly because of overwhelmed enzymes.

These first two challenges of biosimilar development require the right skills to overcome – namely analytics, molecular biology, cellular biology and biochemistry. Bringing these skills together requires a huge effort. A number of service companies have emerged to help plug the gap for these skillsets, but there are also non-profit organizations. One non-profit initiative I would like to call out in particular is MabDesign in France, which was set up in September 2015 to help structure and support the development of therapeutic antibodies and immunotherapies in France. The company already has over 80 members, including immunotherapy developers, service providers, training organizations and equipment suppliers. Biopharma development is becoming ever more complex so collaboration is key. MabDesign has been developing specialized training solutions and setting up scientific events (both regional and international) to help promote networking and innovation.

Of course, in addition to the right skills, the right equipment is also key. Fortunately, vendors are continuously improving their systems and developing new end-to-end solutions. For manufacturers, using the newest and most efficient technologies can provide benefits in terms of cost savings during manufacture.

And what about the problem posed by the vicious competition in the marketplace? Today, almost four hundred biosimilar drugs are under preclinical or clinical development in the world, competing with fifty originators. These development programs are not equally distributed among originators, and the current trends show some opportunities for strategic positioning. It is interesting to note that some originator biologics (trastuzumab, bevacizumab, adalimumab) are currently challenged by more than thirty biosimilar programs – one (rituximab) is faced with more than forty programs. All of these programs are clearly appetized by the topline revenues of the originator biologic – between $6 billion and $8 billion for each – but it seems that many biosimilar drug makers have forgotten that they may only end up with a very thin slice of cake... All of these manufacturers will only have one main point of leverage to be successful once marketed: adapting the product price to the competitive landscape. When considering the cost of biosimilar development (around $80-200 million), the reality of having to share your cake with dozens of competitors must also be considered.

In contrast, other originator biologics, although less attractive from a revenue standpoint, may offer better outlooks for biosimilar drug makers because few competing products are in development. In my view, eculizumab is without question the best example: this originator generates $2.2 billion in revenue, its patent will expire in 2020, and only one drug maker is developing a biosimilar product so far. No doubt that this drug maker has selected a fine cake, and has a more significant chance at success than the developers of rituximab or trastuzumab biosimilars. Time will tell how successful this audacious positioning turns out to be.

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About the Author
Guillaume Plane

Guillaume Plane is Global Development and Marketing Manager, Biodevelopment Services, at Merck KGaA.

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