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Unsealed Price-Fixing Complaint Reveals Emails

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Unsealed Price-Fixing Complaint Reveals Emails Issue 406 • 5 July 2019 knew what they were doing was illegal,” Tong insisted, “and that’s why they sought to mislead Congress, destroyed evidence, and cautioned each other to keep their collusive conversations offline. Our inves- tigation is ongoing and expanding and the evidence released today reinforces the allegations in the complaint.” ‘POLITE F-U LETTERS’ AND ‘CO-OPETITION’ Among the emails highlighted by the Connecticut attorney general’s office is an email from Heritage Pharmaceuticals in which the firm “co-ordinated a response with counsel for Teva and Mylan” to a Con- gressional investigation into price increas- es led by Bernie Sanders and Elijah Cum- mings, who have recently urged criminal Unsealed Price-Fixing action over the current allegations. According to the email addressed to Heritage Pharmaceuticals’ Jeff Glazer, the Complaint Reveals Emails attorney general’s office noted, Teva and DAVID WALLACE [email protected] Mylan had both been in contact with the US Generic Pharmaceutical Association series of emails between gener- the states’ motion to unseal the com- (GPhA) – now known as the Association ics firms published as part of plaint, Tong pointed out, “among the ev- for Accessible Medicines (AAM) – to co- A an unredacted lawsuit alleging idence now public are emails between ordinate the response. “The consensus widespread price-fixing in the US gener- generic drug manufacturers coordinat- at this point is that the response will be ics industry reveals “brazen co-ordination ing their response to a Congressional ‘polite f-u letters’,” the email reads. to artificially inflate prices, hinder com- inquiry, emails enforcing ‘fair share’ and Further written evidence disclosed petition and unreasonably restrain trade ‘playing nice in the sandbox’ market al- by the filing shows firms requesting “no across the industry,” according to Con- location, ‘fluff pricing’ strategy and other emails please – phone call,” which the necticut attorney general William Tong. brazen co-ordination.” attorney general’s office described as an Tong had spearheaded the Connecti- These “commonly-used code-words” attempt to “cover their tracks” and was cut district court complaint filed in May were used to “co-ordinate on price in- “ample written evidence of their conspir- by a coalition of 44 US states, initially in creases in violation of federal antitrust acy…that show consciousness of guilt.” a redacted form, that named Teva, San- law,” the attorney general’s office claims. “In one series of exchanges,” the at- doz and Mylan, along with 17 other ge- “The evidence is undeniable and the con- torney general’s office notes, “senior -ex nerics manufacturers, as being involved spiracy is unconscionable,” Tong stated. “Our ecutives at Mylan and Sandoz allegedly in “a broad conspiracy to artificially inflate lawsuit alleges that generic drug manufac- colluded to divvy up market share for a and manipulate prices, reduce competi- turers engaged in a brazen, industry-wide blood pressure medication” when the tion and unreasonably restrain trade for conspiracy to fix prices and allocate market two firms were first to launch generic val- more than 100 different generic drugs.” share for drugs that we rely on every day.” sartan/hydrochlorothiazide on the same With the court having now granted “The evidence demonstrates that they day, 12 September 2012, with Mylan en- FOR THE LATEST INSIGHT ON GENERICS AND BIOSIMILARS VISIT: GENERICS.PHARMAINTELLIGENCE.INFORMA.COM PRICING BIOSIMILARS REGULATION German Price Henlius Has First ‘China- UK Government Anniversary Shows Developed’ Biosimilar Accepted Plans Express Freight Split In Perspectives, p. 6 For EMA Review, p.12 For Medicines, p.16 IN THIS ISSUE Ongoing price-fixing allegations in the US took another turn this week with the publication of an unredacted version of a multi-state lawsuit alleging collusion and anti-competitive behaviour among some of the industry’s biggest players. While firms are vigorously rebutting the allegations, the details re- from the editor vealed by emails and other evidence cited in the price-fixing [email protected] lawsuit (see front cover) have led to negative headlines and coverage for the industry in the mainstream press. Also this week, Akorn has received a further warning letter from the US Food and Drug Administration, exacerbating its compliance woes (p.4). And Glenmark has received a complete response letter from the agency over its Ryaltris nasal spray, pushing back approval into next year at the earliest (p.5). It has not all been bad news this week, however. Biocon has been bolstered by a European approval for one of its key bio- similar manufacturing sites, opening doors in Europe for the Indian firm (p.9). And Shanghai Henlius Biotech has broken “While firms are new ground after its trastuzumab candidate became the first vigorously rebutting ‘China-developed’ biosimilar to have a marketing authoriza- the allegations, tion application accepted for review by the European Medi- cines Agency (p.12). details revealed by emails cited in Meanwhile, in the UK preparations for Brexit continue, with the price-fixing contingency planning – including express freight arrange- ments to ensure continuity of supply – being met with a lawsuit have led to guarded welcome from the country’s pharmaceuticals and life negative headlines” sciences sector (p.16). LEADERSHIP SUBSCRIPTIONS DESIGN SUPERVISOR Phil Jarvis Val Davis Gayle Rembold Furbert Mike Ward ADVERTISING PRODUCTION Karen Coleman Rob Coulson Debi Robinson EDITOR IN CHIEF Eleanor Malone CUSTOMER SERVICES TO SUBSCRIBE, VISIT [email protected] generics.pharmaintelligence.informa.com EXECUTIVE EDITOR Aidan Fry UK & Europe. +44 (20) 337 73737 TO ADVERTISE, CONTACT [email protected] EXECUTIVE EDITOR David Wallace US Toll-Free . +1 888 670 8900 EDITORIAL OFFICE US Toll . +1 908 547 2200 SENIOR REPORTER Akriti Seth 4 Poplar Road Australia ��������������������������� +61 2 8705 6907 Dorridge, Solihull B93 8DB CUSTOM CONTENT Andrea Charles Japan ��������������������������������� +81 3 6273 4260 All stock images in this publication courtesy of Generics Bulletin is published by Informa UK Limited. ©Informa UK Ltd 2019: All rights reserved. ISSN 0143 7690. www.shutterstock.com unless otherwise stated 2 | Generics Bulletin | 5 July 2019 © Informa UK Ltd 2019 7 16 20 exclusive online content inside: Sandoz Data Suggest Safety And COVER / Unsealed Price-Fixing Complaint Reveals Emails Efficacy In Adalimumab Switching Sandoz presented data at EULAR 2019 proving the safety 4 Akorn Receives Second Warning and efficacy of switching from reference brand Humira Letter In Six Months to Hyrimoz, the company’s biosimilar adalimumab. https://bit.ly/2JiAO4r 5 Glenmark Suffers US Ryaltris Setback Amid Search For A Partner European Industry Backs 6 German Price Anniversary Shows Split In Perspectives Commitment To Access A renewed commitment to European access to healthcare 7 Sandoz Will Consider Local Partnerships In China made by the European Council has received the backing of industry, which has set out six key policy proposals. 9 Biocon’s Biosimilar Ambitions Get https://bit.ly/2Xf4XXi A Boost With European Site Approval People Round-Up: Saraf Heads 10 Top US Generics Players Thwarted On Amneal’s Corporate Development August At-Risk Launch Of Fingolimod Apurva Saraf heads up corporate development for Amneal, Salvatore Butti becomes Stada’s general manager in Italy 12 Henlius Has First ‘China-Developed’ and Vectura searches for a new CEO. Biosimilar Accepted For EMA Review https://bit.ly/2XFWK2x 13 API Manufacturing Must Be High On Europe’s Agenda US FDA Will Allow Transitioning Products To Continue Referencing 16 UK Government Plans Express Freight For Medicines Drug Master Files 17 AAM Maintains Pressure On USTR To Shield The ‘technical detail’ needed to be resolved in part to Pharmaceuticals From China Tariffs ensure there would be no shortages after the 2020 change from regulation as drugs to biologics for certain protein 19 Coherus Chief: FTC Must Probe Originators’ products, the agency said. Anti-Competitive Tactics https://bit.ly/2XdJazn 20 Mayne Cannot Revive US Antifungals Patent Industry Prepares For Advent Of SPC Manufacturing Waiver 20 Spain’s Aeseg Warns Against Tender Proposals As the generics and biosimilars industries prepare for the 21 US Court Sticks To Status Quo European SPC manufacturing waiver to come into effect on 1 On Rotigotine Patch July, Generics Bulletin traces the history of the mechanism from early industry lobbying efforts to its ultimate entry into force. 22 Oklahoma Judge Okays $85m Teva https://bit.ly/2YrU7P4 Opioid Out-of-Court Settlement China Releases List To Encourage Competition China’s National Health Commission issues list of 34 generic drugs that have ‘insufficient’ competition, seeking public comments. /company/genericsbulletin https://bit.ly/2XhvyrH @genericbulletin genericsbulletin.pharmaintelligence.informa.com 5 July 2019 | Generics Bulletin | 3 PRICING joying 180-day exclusivity and Sandoz mark and Taro were top-ranked, accord- “Like all products sold in a free market, launching an authorized generic via par- ing to the complaint, with Apotex and prices of pharmaceuticals are subject to ent company Novartis. Zydus lowest-ranked. a broad range of factors, but market data “Leading up to the launch, records shows that average prices in the gener- show company representatives spoke at SANDOZ AND MYLAN ‘VIGOROUSLY’ ics industry have been going down year
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