Politics, Biosimilars and New Medicines and Technologies for the Future

By: Stephanie Sutton, Editor, The Medicine Maker

I’ve been writing about the pharmaceutical industry for close to a decade now. Part of what I love most about my current role is being able to report on a wide variety of topics and issues relevant to pharma, from ways to improve manufacturing efficiencies, to business trends, to groundbreaking research. Over the years, I’ve had the opportunity to speak with many truly inspirational and brilliant individuals. It makes me wish I had studied science rather than journalism at university….

I have been asked to write two blogs for this website. However, there are so many advances and changes happening in pharma at the moment that it is incredibly difficult to narrow things down to just two topics! Therefore, for this first blog I’d like to highlight a selection of key trends and advances in the industry that we have tackled in The Medicine Maker (https://themedicinemaker.com/) in recent months.

Political discord

When talking about current industry trends it’s impossible to overlook current global politics. Some of the biggest discussion points in the industry right now relate to the potential impact of “Brexit” and the election of a new US president. It’s not yet known exactly how these events will impact pharma – as well as other global industries – but it seems unlikely that it will simply be business as normal. In terms of Brexit, trade disruption is likely, as well as big changes for the European Medicines Agency, which is currently located in London. As for the US, President Trump’s actions are unpredictable, but the pharma industry has definitely been on the receiving end of his comments and speeches. He has also vowed to bring down drug prices.

In our February 2017 issue (see https://themedicinemaker.com/), George A Chressanthis, from Axtria, tries to predict what policy actions Trump is most likely to take and their potential impact on pharma. Policy actions on intellectual property protection and tax/financial reforms could be positive for pharma, whereas policies on drug pricing, labor immigration and international trade, are likely to have a more negative impact.

Biosimilars

The US finally approved the country’s first biosimilar in 2015. Biosimilars, of course, have been available in Europe for many years, but the opening of the US market was a crucial moment – and 2016 has ended with a long list of products under regulatory review. According to Eva McLellan and Martyn Smith, who contributed to the October issue of The Medicine Maker (https://themedicinemaker.com/issues/0916/bluff-or-serious-biosimilar-bet/), biosimilars are a hot topic for the industry because their impact extends across all phases of a biopharmaceutical product’s lifecycle – the issue of biosimilars is often raised in cell line development, manufacturing, analytical characterization and commercialization.

At the moment, the biosimilars industry is still finding its feet. Some early leaders have surged ahead, but the game could change – McLellan and Smith emphasized that the next decade will be a fascinating one to watch in terms of market dynamics. In the January issue of The Medicine Maker, Catherine Godrecka-Bareau (https://themedicinemaker.com/issues/0117/biosimilars-come-fly-with-me/) also argued that there is room for improvement in the biosimilars model; in particular, she explains that biosimilars companies could learn a thing or two from the airliner industry in terms of de-risking, optimizing costs and maximizing sales.

New treatments

Up until a few years ago, it was common to hear the media criticizing pharma for its “innovation drought”. The lack of innovation was attributed to a number of reasons, including the rising costs of research and development, and the economic crisis. Today, however, we are seeing continued successes in immuno-oncology and growing excitement around checkpoint inhibitors. There is also the rise of cell therapies and gene therapies. In January, we published a roundtable article (https://themedicinemaker.com/issues/0117/revelations-and-resolutions/) featuring Markus Thunecke (Catenion), Christa Myers (CRB), John Talley (Euclises Pharmaceuticals) and Eva McLellan (Roche) that I believe really showcases the fact that the future of medicines is bright. Siu Ping Lam, Director of the Licensing Division at the UK’s MHRA, also added: “Personally, I think 2016 has been a very exciting and busy year. A great number of new medicinal products have been authorized and the pharmaceutical industry is predicting that more new active substances are coming to fruition in 2017 and beyond.”

New technologies

Increasing innovation is also being seen in terms of new technologies that help improve the manufacture of drugs. A big focus for The Medicine Maker is on enabling techniques, technologies and processes that facilitate drug development and manufacturing. At the moment, “continuous manufacturing” and “flexible manufacturing” are key buzz words, with a number of new equipment launches being seen during 2016. Interesting advances are also being seen in formulation technologies, particularly in terms of overcoming API solubility challenges.

Every December, The Medicine Maker publishes its Innovation Awards (https://themedicinemaker.com/issues/1116/innovation-returns/). The Innovation Awards recognize the most exciting drug development and manufacturing technologies released over the year – with the overall winner for 2016 being MilliporeSigma’s Centinel technology. A variety of different technologies were highlighted in 2016 – and I think it showcases that the entire pharma industry, both manufacturers and vendors, is packed with innovation right now.

The Medicine Maker covers a variety of emerging technologies and trends in the pharma industry. Read more or sign up for a free subscription at: https://themedicinemaker.com/login/

About INTERPHEX

Official blog of: INTERPHEX New York - www.interphex.com
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