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Sandoz Closes in on US Filgrastim Biosimilar

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Sandoz Closes in on US Filgrastim Biosimilar Gen 16-1-15 Pg.1_Gen 18/11/05 Pg. 1 13/01/2015 16:40 Page 1 16 January2015 COMPANY NEWS 2 Sandoz closes in on US Abdi Ibrahim teams with Algerian player 2 Kremers deal falters 3 after US FDAaction Tianyin teams up to tackle its troubles 4 filgrastim biosimilar nod Apotex and Panacea allyovertwo drugs 5 US business booms to aid Zydus Cadila 6 andoz has taken amajor step towards securing the first approvalthrough the US Strides starts work on Malaysian facility 7 Sbiosimilar pathway after an advisory panel to the US Food and Drug Administration Walgreens completes 8 (FDA) recommended the agency should approve the company’s EP2006 filgrastim Alliance Boots deal candidate with all the same indications as its reference product, Amgen’s Neupogen. “Weare pleased with the Oncologic Drugs Advisory Committee’s(ODAC’s)recommendation MARKET NEWS 9 to approve our biosimilarfilgrastim and we look forward to continuing to work with FDAas it completes its reviewof our filing,”said Sandoz’ Mark McCamish. If the agencyfollows Suspensions in EU followGVK review 9 the committee’snon-binding advice, Sandoz proposes to market biosimilarfilgrastim pre- Four firms shareinSouth African tender 11 filled syringes in the US under the brand name Zarxio. Abriefing documentfor the ODAC meeting on 7January stated that “considering the Te va takes top spot among AOKawards 12 totality of the evidence, the data submitted by the applicant showthat EP2006 is highly similar GPhA voices concern 13 to US-licensed Neupogen. The clinical data have shown that there are no clinically meaningful over TPP provisions differencesbetween EP2006 and US-licensed Neupogen, suggesting that EP2006 should receive Russia mayconsider compulsorylicensing 14 licensure for each of the five indications for which Neupogen is currently licensed”. The proposed commercial product was“analytically highly similar” albeit with a“slightly PRODUCT NEWS 15 lower” protein content than Neupogen, an issue that “may be resolved by manufacturing and control strategies”. In response, Sandoz submitted additional data analysing the protein- FDAaccepts Apotex’ filing 15 concentration levels of clinical and commercial EP2006 batches against Neupogen licensed of pegfilgrastim in the US and European Union (EU). The FDAdeclared its satisfaction that commercial and Zydus Cadila debuts adalimumab in India 17 clinical batches of EP2006 had “the same strength” as US-licensed Neupogen. Furthermore, a reanalysis of immunogenicity data confirmed that EP2006 and Neupogen had “similarly low To rrent and Reliance 18 rates of anti-drug antibody(ADA) in treated subjects”. strikebiologics deal To support its application, Sandoz submitted five clinical studies for subcutaneous doses Sandoz’ filgrastim is introduced in Japan 19 between 1µg/kg and 10µg/kg. Twotrials used US-licensed Neupogen as the reference product US firms introduce their Celebrex rivals 20 to demonstrate safety and efficacyusing endpoints including pharmacokinetics and absolute NZ awards Remicade 21 neutrophil count. The other three trials used EU-approvedNeupogen. G sole supplyto2020 Sandoz appeal fails over US etanercept 22 Te va eyes EU launch 23 INNs become mandatoryinFrance forCopaxone 40mg octors in France must use the international non-proprietary names (INNs) of medicines on Dall prescriptions from 1January,under legislation issued by the country’shealth ministry. FEATURES 26 The requirement –first outlined in apackage of measures introduced in 2011 –was confirmed in adecree published in France’s Official Journal towards the end of last year.Brand names Eastern expansion and OTC26 may still be used alongside INNs. featurefor Mylan in Europe Catherine Bourrienne-Bautista of France’sgenerics industry association, Gemme, told Te va is to makemorefrom28 Generics bulletin that strict INN prescribing would help to develop the use of off-patent less sales in fewermarkets medicines that are not included in the country’s répertoire of substitutable generic equivalents, such as paracetamol. It could also aid patients’ understanding of the medicines being prescribed, REGULARS Bourrienne-Bautista suggested. However, the impact of the change would be limited, she acknowledged. France’sgenerics industry already benefits from amechanism of pharmacy Events – Our regular listing 24 substitution for all eligible prescriptions. Price Watch UK – Our in-depth 25 While the requirement to use INNs entered into force at the start of this year,Bourrienne- look at pricing trends in the UK Bautista predicted that electronicprescribing software used by doctors would not be ready to People – Endo seeks aleader for 30 incorporate the change for around six months. She also acknowledged the reticence on the part its Qualitest unit of certaindoctors to accept the newrequirement. Local medical union CSMF has described the measure as “an extra complication for doctors”. G Gen 16-1-15 Pgs. 2-8_Layout 1 13/01/2015 16:19 Page 2 COMPANY NEWS MANUFACTURING STRATEGICALLIANCES Reddy’sand Ipca to Abdi Ibrahim teams halt Canada exports with Algerian player rReddy’sLaboratories and Ipca Laboratories have agreed to urkey’s Abdi Ibrahim has formed apartnership with leading DHealth Canada’srequest that theyquarantine certain products TAlgerian pharmaceutical player RemedePharma. As part of the manufactured in India due to “data-integrity concerns”. deal, the Turkish companyhas undertaken to open by the beginning “In keeping with the current regulations of Health Canada,” of 2016 alocal facility that complies with good manufacturing Reddy’sstated, “the companyhas voluntarily placed under quarantine practice (GMP) standards. all active pharmaceutical ingredients (APIs), and formulations based Operating under the name Abdi Ibrahim RemedePharma, the on APIs, produced at our API facility in the Srikakulam district of venture will “unite the power of the twocompanies to produce and Andhra Pradesh.” market avariety of products addressing awide range of treatments”. Stressing that it wasworking with the agencytowards reaching As part of the agreement, Abdi Ibrahim –which has operated in a“satisfactory resolution”, Reddy’ssaid it believedits products met Algeria since 1999 –has acquired shares in RemedePharma. “intended quality standards” and posed no risk to health. “The synergy created by the combination of RemedePharma’s The move to quarantine drugs had, the Indian companyadded, “no knowledge of the Algerian market dynamics and our company’sfocus implication on anyactivity at the plant” at present, so would not affect on international targets will makeimportant achievements,”stated the group’soperations or financial results. Abdi Ibrahim’schairman, Nezih Barut. The group, he pointed out, Similarly,Ipca –which is already subject to an import ban on APIs nowboasted production facilities in Algeria, Kazakhstan and Turkey. made at its plant in Ratlam, India (Generics bulletin,17October 2014, RemedePharma’sowner,Lamine Bousteila, said the Turkish group’s page 8) –said it did not “generate anymaterial business” in Canada expertise would be “invaluable” in constructing the GMP-compliant from its affected formulationsfacility in Indore, Pithampur. facility and expanding the Algerian firm’sproduct portfolio. Describing the voluntary quarantine as a“precautionary step in Just overUS$50 million of Abdi Ibrahim’s2013 turnoverof viewofUSFood and Drug Administration (FDA) audit observations TL813 million (US$349 million) came from international markets. made regarding good manufacturing practice (GMP) deficiencies at Having established its ownoperations in Algeria, Azerbaijan, Georgia the said manufacturing unit”, Ipca stressed it was“fully committed” and Kazakhstan, the group towards the end of last year struck a to resolving the issue at the earliest opportunity. G licensing deal with Saudi Arabia’sDeef. G 2 GENERICS bulletin 16 January2015 Gen 16-1-15 Pgs. 2-8_Layout 1 13/01/2015 16:19 Page 3 COMPANY NEWS MERGERS&ACQUISITIONS MERGERS&ACQUISITIONS Sun and Ranbaxy to Kremers deal falters divestseven in India after US FDA action un Pharma and Ranbaxy have cleared ahurdle in their bid to US$1.53 billion transaction through which Kremers Urban Sclose on their proposed US$4 billion merger by agreeing to divest APharmaceuticals (KU) –the US generics arm of Belgian biopharma sevenfinished-dose formulations on the orders of the Competition firm UCB –was due to be acquired by private-equity firms Advent Commission of India (CCI). The deal –which wasfirst announced International and Avista Capital Partners has been terminated by the in April (Generics bulletin,18April 2014, page 1) –now requires firms, following action taken by the US Food and Drug Administration approvalfrom the US Federal Trade Commission (FTC). (FDA) overthe generics firm’slocal rivaltoJanssen’sConcerta According to the prospective partners, the products to be divested (methylphenidate) extended-release tablets. “constitute less than 1% of the combined entity’srevenues in India”. The FDArecently stripped KU of its ‘AB’ bioequivalence rating To gain the CCI’sapproval, Sun has agreed to divest its Tamlet for its generic version of Concerta following concerns overwhether (tamsulosin/tolterodine) brand, which holds around athird of the generic rivals to the brand –also including aversion marketed by Indian market, with Ranbaxy’sRoliflo holding nearly two-thirds and Mallinckrodt –were equivalent (Generics bulletin,5December 2014, Intas aminor share. page 23). UCB said it had “mutually agreed” with Advent and Avista Ranbaxy will divest its distribution
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