Therapeutic Proteins’ Biosimilar Quest

biosimilarsToday Crain’s Chicago ran an article on Therapeutic Proteins and the unique technology the utilize to efficiently manufacture biosimilars.

With a shorter approval process interchangeable biologics can provide increased patient access to biologics medicines, but they are much more complex than small-molecule generic drugs.

The biosimilars marketing has huge potential in the US. Going on almost 8 years now the “Guideline on similar biological medicinal products” came into effect in Europe, providing an overarching framework for obtaining approval for a biosimilar in the European Union. This paved the way for the subsequent launch of 14 biosimilar products in three molecule classes. Hospira already has five plus years of experience providing biosimilars to the European market and has delivered more than 5 million doses of biosimilar medicine to patients in Europe and Australia.

According to a McKinsey report, overall, the financial results from biosimilars have been poor so far. Sales from the second half of 2010 to the first half of 2011 were about $400 million, with cumulative sales since 2006 of approximately $1.2 billion. This must be seen in the light of R&D and manufacturing investments of approximately $1 to $1.5 billion across the seven biosimilar dossiers approved to date.

However, there are promising signs. Although biosimilars’ penetration rates, in general, have not been as high as those for small-molecule generics, nor as consistent across countries or molecules, they are improving. Growth and uptake rates and the number of countries with more than 50 percent penetration have improved for every new molecule class that has seen biosimilars.

258153_13678396750709_3Estimates of the future size of the biosimilars market range widely, from $2 billion to $20 billion by 2020. To date, entry has been relatively straightforward: only a few molecule classes have gone off patent, they have not been the biggest commercially, and they include only the simpler proteins. The question is what will happen once the real game begins, with biosimilars of more complex molecules, the entry of numerous molecule classes, and products worth more than $5 billion coming under pressure.

lcKeep in mind this is all in the EU and other countries, while the Affordable Care Act in 2010 provided guidance for the U.S. Food and Drug Administration (FDA) to oversee approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor’s prescription and whether a pharmacist must inform patients and doctors are covered by state law.

Currently in Springfield there is legislation to provide this governance (SB 1934), and until it is passed in Illinois (and in other states) doctors will not be able to substitute interchangeable biologics. It is very similar to the bill passed in Indiana earlier this year. But in Illinois the opposition has been very strong, especially on the issue of Doctor notification of substitution. In Illinois doctors are not notified by pharmacists if they use a generic small-molecule drug instead of a branded drug as prescribed (there are exceptions for epilepsy drugs and a few others).

“Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely,” said BIO CEO James Greenwood. “Unlike conventional generic medicines, interchangeable biologics are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same. Those suggesting interchangeable biologics and generics are the same are wrong.”

Patients should have access to all potential life-saving medicines including biosimilars . But since generic substitution laws were written before biosimilars even existed, current laws need to be rewritten to accommodate the emergence of biologics and biosimilars in the marketplace.

I believe that sound policy in outlining parameters for safe substitution of interchangeable biologics is the best option to ensure patients have access to high-quality, safe and effective biologic medicines.

The legislation (SB 1934) provides transparency, protecting the primacy of the physician-patient relationship. Physicians and their patients should be in the best position to determine appropriate therapies. Physicians need to be aware of substitutions in order to assess a patient’s response and further treatment options.

In fact, pharmacists currently communicate with physicians about patient immunizations and influenza vaccinations, so physician communication in regards to biosimilar substitution is simply an extension of that communication

The FDA does not currently have a timeline in place for guidance on interchangeable biologics and may not have them in place by the time the first biosimilar comes to market, which could be as soon as next year. Therefore, our legislators have a responsibility to the patients and their families of Illinois to be prepared.

I believe that lawmakers have an obligation to pass substitution legislation in order to create a pathway for the use of biosimilars.

“Bringing biosimilars to the United States is the next major step toward reducing costs for the U.S. healthcare system,” said Thomas Moore, president, U.S., Hospira. “As the first U.S. company to market biosimilars globally, Hospira will build on our track record of success to introduce biosimilars in the United States and increase access for Americans to high-quality biologic medications that treat severe and life-threatening diseases.”

Therapeutic Proteins began clinical trials in April and plans to apply in the fall to license its product.

Therapeutic Protein's CEO, Sarfaraz K. Niazi

Therapeutic Protein’s CEO, Sarfaraz K. Niazi

Therapeutic Protein’s CEO Sarfaraz K. Niazi launched his company in 2003 with $1 million from friends and other investors. It has about 200 employees today, fueled by $75 million in investments in 2012, including from brothers Chirag and Chintu Patel, co-founders of Amneal Pharmaceuticals LLC in Bridgewater, New Jersey.

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