< Previous INTELLECTUAL PROPERTY AND PATENTS 30 Pharma Business International www.pbiforum.net Patent and Trademark Office’s inter parties review process (IPR). Numerous pharma companies have expressed concerns that the process disadvantages holders of patents, specifically because IPR reviews remain separate from the federal court. Allergan courted controversy when they attempted to wriggle past the IPR review and were caught doing so – prompting wide-spread criticism and controversy, as well as a move by the US Congress to close what they called a “brazen loophole”. Allergan came out with defence of their actions, of course, but it’s undeniable that this – along with numerous price-raising strategies of pharma giants – has turned Governments against the sector, creating an obvious “us versus them” divide. This is dangerous in the long-term and not worth any immediate gains companies may receive, and yet it has become a staple part of the industry. It’s not just the US where things are going poorly, however. In the EU, the same year-on-year price increases in drugs has courted controversy, and has led to the suggestion that the EU will repeal the SPC (Supplementary Protection Certificate) mechanism for medical products. The SPC helped to protect and extend monopoly rights for originator © Shutterstock /becky’s 28-31.qxp_Layout 1 07/06/2019 13:03 Page 3Pharma Business International 31 www.pbiforum.net INTELLECTUAL PROPERTY AND PATENTS pharmaceutical companies, an impressive and valuable tool for intellectual property – and yet it seems that the greed of the few may soon turn the EU against the many. As a result, several groups and agencies, including Oxfam, MSF and EATG, have sent an open letter to the Commission recommending them to abolish the SPC mechanism and improve transparency. In times past the sector might have been able to call on support from the public over what may mean an influx of pretender drugs to the market if the SPC mechanism is revoked. However, media highlighting of the price-increase strategies of some (including but not limited to Martin Shkreli) have turned much of the public against pharmaceutical giants as well. It is not a good period for pharmaceutical companies from a legal or ethical point of view, and when it comes to intellectual property it is worth remembering that those who write the laws are the ones companies should feel most inclined to court and woo. Short- term profit strategies that come at a potential risk to the long-term survival of the industry are not the way forward. It is a technique that was tried before by British Banks, and everyone has seen how that ended. 28-31.qxp_Layout 1 07/06/2019 13:03 Page 4BIOSIMILARS 32 Pharma Business International www.pbiforum.net Bring on the biosimilars With more and more pharmaceutical firms shifting their focus to biosimilars, we explore the state of the market, what’s driving growth and what barriers still need to be overcome. 32-35.qxp_Layout 1 07/06/2019 13:04 Page 1Pharma Business International 33 www.pbiforum.net BIOSIMILARS © Shutterstock /Proxima Studio I n 2006, Omnitrope became the first biosimilar medicine approved in Europe, followed a decade later with the approval of Sandoz’s Filgrastim-sndz in the United States. There are now twenty-five biosimilars approved in Europe and eleven in the US and since those milestone moments, the biosimilars market has continued to grow exponentially and is forecast to reach $61.47 billion by 2025. Market growth is being predominantly driven by the growing number of important biological drugs approaching the patent cliff, that is to say losing their exclusivity and allowing cheaper versions to be manufactured and sold. For example, several companies – including Amgen, Boehringer Ingelheim and Pfizer – are all currently developing (or are in the process of submitting) a biosimilar drug of rituximab, the patent of which expired back in 2015. The market will also continue to be boosted by the overall lower costs of biosimilars compared to their patented biologic counterparts and the growing number of positive outcomes observed in clinical trials. On this front oncology is faring best and, indeed, it held the biggest slice of the biosimilars market in 2016 due to the increasing adoption of low-cost biosimilar drugs being used in cancer treatments. A win, it would seem, for both buyers and patients. In order to achieve market approval, these medicines must, of course, possess little variance from their original biologics in terms of structure, but they 34 Á 32-35.qxp_Layout 1 07/06/2019 13:04 Page 2BIOSIMILARS 34 Pharma Business International www.pbiforum.net must also maintain similar safety and efficacy. For that reason, regulators don’t require data from Phase II clinical trials in order to approve new biosimilars. The focus is instead put on determining biosimilarity through rigorous analytical studies. The reason being because Phase II trials explore the efficacy of a drug, as well as discovering more about side effects and how to manage them, as well as the best dosage. As these trials have already been undertaken and data collected, collated and assessed during the approval of the reference biologic, efforts can instead be focussed on ascertaining the biosimilarity of the perspective medicine. Though this is undoubtedly attractive, the biggest motivator behind the growth of the biosimilars market is, almost undoubtedly, price related. A company that owns the patent for a treatment has a monopoly and can effectively charge what they want. Patents on drugs filed since 1996 last for twenty years from the date of application filing. After expiry, any given number of companies can then develop their own version of the same drug. All of this adds to a much more competitive marketplace as pricing wars break out and drive costs down. Price discounting and competition are already having a major impact on the biosimilars market, especially in Europe where the attentions of manufacturers are increasingly focussed as the US still lags behind. It’s not uncommon for drug makers to offer up to seventy per cent discounts for their treatments as competition tightens. It’s not a state of affairs brought about solely by pharmaceutical companies, however, but 32-35.qxp_Layout 1 07/06/2019 13:04 Page 3Pharma Business International 35 www.pbiforum.net BIOSIMILARS © Shutterstock /HQuality by increasingly savvy buyers coordinating pricing wars between suppliers. While bigger companies will fare better, new market entrants are having to compete more aggressively in order to capture a market share. Analysts say that this pervasive discounting will likely continue, with competition only increasing as more patents expire and multiple versions of the same treatment are commercialised at the same time. As we’ve already explored, pricing is a crucial variable in the success of any biosimilar. In short, the more a drug marker optimises for price, the greater leverage it creates in its commercial buyers. However, professional services network Deloitte argues that although a generic drug might cost seventy per cent less than its branded counterpart, biosimilar makers have been unable to offer prices that are much lower than the originator biologic because, it says, manufacturing costs for biosimilars are much higher, and makers must also invest in marketing and sales. According to the peer-reviewed journal American Health & Drug Benefits , it takes seven to eight years to develop a biosimilar, at a cost of between $100 million and $250 million. Pricing issues will persist as the biosimilars market expands, but there exist other challenges such as making biosimilars more attractive, particularly in the US. Reducing the development and manufacturing costs of biosimilars will also be crucial to unlocking growth, whilst more needs to be done to curb the practices of original drug makers fighting against competitors of biosimilar drugs. 32-35.qxp_Layout 1 07/06/2019 13:04 Page 4Tuesday 25 June Pharma Social Media One America Square, London This event will see 21 pharma industry leaders including Roche, Merck, Pfizer, GSK and more share their insights into driving patient & HCP engagement, demonstrating value and securing buy-in whilst ensuring compliance with targeted, impactful strategies which prove social media as a strategic form with measurable impact. To find out more, email info@pharmasocialconference.com. Thursday 27 – Friday 28 June 18th Annual Congress on Pharmaceutics and Drug Delivery Systems Holiday Inn Amsterdam, The Netherlands Designed to keep attendees abreast of the very latest developments in the world of pharmaceutics and drug delivery systems, this conference will utilise interactive panel discussions, keynote lectures, plenary talks and poster sessions. It will emphasise anticancer drug delivery for tumour targeting; drug targeting and design; nano-medicine and nanotechnology, and novel drug delivery systems, among other topics. For more information, email pharmaceutics@europemeet.com. Pharma EVENTS © Shutterstock / Princess_Anmitsu 36 Pharma Business International www.pbiforum.net © DrimaFilm / Shutterstock.com Monday 29 – Tuesday 30 July 7th European Biopharma Congress Stockholm, Sweden The latest instalment of the European Biopharma Congress will explore various disciplines involved in drug discovery, pharmaceutical manufacturing, novel drug Wednesday 3 – Friday 5 July i- Pharma UK Park Inn by Radisson Heathrow, London The annual i- Pharma conference and expo is the largest gathering of pharma and healthcare professionals in the UK and Europe. The event is packed with workshops, symposiums and multiple plenary sessions focussing on thought provoking discussions and peer-led networking. All of which makes it the ideal venue to learn about the latest trends shaping the pharma industry and to gain new skills and insights from industry experts. To find out more, visit www.ipharmaconference.com. Thursday 4 – Friday 5 July Pharmacovigilance & Drug Safety Barcelo Valencia, Spain This timely conference will explore the rapidly expanding field of pharmacovigilance which is having a massive impact on medical science and pharmaceuticals. This year’s keynote speakers include Stanley Cohan from Providence Multiple Sclerosis in the US, and Tarik Messaoud, a Drug Safety Specialist in Merck, Canada. To find out more, email pharmacovigilance@expertsgathering.org. Wednesday 26 – Thursday 27 June Health & Care ExCeL London With a focus on the future of healthcare in the UK, this event offers a rare opportunity for colleagues across the NHS, local government, care homes and the voluntary sector to come together on an equal footing to network, collaborate and share learning around implementing change. For more information, visit www.healthpluscare.co.uk. 36-37.qxp_Layout 1 07/06/2019 13:04 Page 1delivery systems, nanotechnology, radiopharmaceuticals, clinical trials, packaging and marketing. For more information, email biopharma@europemeet.com. Tuesday 17 – Wednesday 18 September Recalls, Returns & Removals Summit Sheraton Silver Spring Hotel, Maryland Hosted by the CBI, this summit will allow attendees to navigate and understand the global recall space; manage automation to effectively return recalled products; reduce cybersecurity concerns and vulnerabilities in devices, and effectively complete field action decisions and health hazard evaluations, among other topics. For more information, visit www.cbinet.com. Tuesday 5 – Thursday 7 November CPhI Worldwide Messe Frankfurt, Germany The world’s largest pharmaceutical exhibition, CPhI worldwide houses six zones representing each stage of the pharmaceutical supply chain – from APIs, machinery and packaging, to outsourcing and biopharmaceuticals. Uniting over 45,000 visiting attendees and 2,500 international exhibitors, CPhI Worldwide is the place to network and source cost-effective pharma solutions from all over the world under one roof. For more information, visit www.cphi.com. www.pbiforum.net Pharma Business International 37 © CL-Medien / Shutterstock.com Wednesday 3 – Friday 5 July INTERPHEX Week Japan Tokyo Big Sight Bringing together four exhibitions for pharmaceutical technologies – INTERPHEX Japan; in-Pharma Japan; BioPharma Expo and PharmaLab Japan – INTERPHEX Week Japan 2019 will bring together over 1,200 exhibitors and 300 speakers, making it one of the largest pharma industry events in Asia. For more information, visit www.interphex.jp/en-gb. Monday 12 – Friday 16 August The Bioprocessing Summit Seaport World Trade Centre, Boston The Bioprocessing Summit brings together more than 1,500 international bioprocess professionals to share practical solutions for today’s bioprocess challenges. Now in its eleventh year, the event has grown to include 16 distinct meetings with weeklong programming covering topics such as cell and gene therapy production, formulation and analytic development. It also includes short courses and training seminars that provide in-depth coverage of critical bioprocess topics. To find out more, visit www.bioprocessingsummit.com. 36-37.qxp_Layout 1 07/06/2019 13:05 Page 2FEATURES Antibiotic resistance exposé Vaccines The answer to opioids Manufacturing Packaging Next issue: Deadline - 24th July 2019 REGULARS News Events M&A Round-up Eye on approvals Visit us at www.pbiforum.net where you’ll find the latest news as it breaks – and why not subscribe to our newsletters so you can have the latest news emailed to your inbox, in between printed issues? @pbiforumwww.pbiforum.net company/po-business-international 38.qxp_Layout 1 07/06/2019 13:05 Page 1Next >