Gen 3-11-17 Pg.1.Indd 1 01/11/2017 17:35 COMPANY NEWS
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3November 2017 COMPANY NEWS 2 Aristo buys Amneal in Nordics and Spain 2 Eight EU authorities are Biocadisgearing up to market in Europe 3 Sandoz enjoys Rixathon 4 and Erelzi start deemed equivalent to US Akorn Grand Avenue facility received 483s 5 WBA is set to shut 600 stores in the US 6 CVS and Anthem ally for a 7 ight European Union (EU) national authorities have been recognised as “capable of PBM deal in US Econducting inspections of manufacturing facilities that meet US Food and Drug Finnish price reform exacts toll on Orion 8 Administration (FDA)requirements” by the US agency, as part of agoodmanufacturing practice (GMP) mutual recognition deal struck by European and US regulators earlier this MARKET NEWS 10 year. Authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK were IndustryurgesactiononSPC waiver in EU 10 recognised under the agreement, in what the FDA called an “important milestone”. US attorneys aiming to 11 “Beginning 1November, we will take the unprecedented and significant step forward in widen suit’s scope realising the key benefits of the mutualrecognition agreement with our European counterparts EMA continuityplannot business as usual 12 in that we will now rely on the inspectional data obtained by theseeight regulatory agencies,” Commission admitstoPUMA plan failure 13 stated DaraCorrigan, the FDA’s acting deputy commissioner for global regulatory operations US$54bn in savings fromUSbiosimilars 14 and policy. “The progress made so far puts us on track to meet our goal of completing all 28 Health Canada plans labelling 15 capability assessments in the EU by July 2019.” fee overhaul Underthe terms of the agreement, the FDA was due to have completed an assessmentof “at least eight EU member states” by 1November, gradually expanding these assessments to PRODUCT NEWS 18 all member states by mid-2019(Generics bulletin,10March 2017, page 1).InJune2017, the Fluticasone is among new 18 European Commission determined that the FDA “has the capability, capacity and procedures FDA guidances in place to carry out GMP inspections at alevel equivalent to the EU”. Sandoz resubmits EU pegfilgrastim dossier 19 “The completion of these capability assessments enables the FDA and the EU to avoid Germany is missing biosimilars potential 20 duplication of drug inspections and allows regulators to devote more resources to other Biomm hits ablock on 21 manufacturing facilities in countries where there may be greater risk,” the FDA pointed out. Brazilian glargine “At atime in which medical product manufacturing is truly aglobal enterprise,” said FDA Mylan sued in the US over insulin glargine 22 Commissioner Scott Gottlieb, “there is much to be gained by partnering with regulatory counterparts to reduce duplicative efforts and maximise global resources while realising the Swiss court upholdsanSPC for Truvada 23 greatest bangfor our collectiveinspectional buck.” Through the partnership, Gottlieb said, “we US opioid crisis is anational emergency 24 can create greater efficiencies and better fulfill our public health goals”. G FEATURES 30 Impax and Amneal eye new 30 channels for US distribution Becoming aleader in alternative direct-to- Hikma is Company of the Year patient distribution is among the numerous benefits that Amneal and Impax expect to ikma was namedCompanyofthe Yearatthe Global Generics &Biosimilars Awards, heldon drive future growth as acombined company. H24 October in Frankfurt, Germany,byGenerics bulletin and co-hostedbyQuintilesIMS. Dean Rudge reports. Meanwhile, Accord Healthcare took home three prizes. The Intas subsidiary won the award for Acquisition of the Year, sponsored by Pharmawise, for its £603 million (US$791 million) REGULARS purchasefromTeva of the former Actavis business in the UK and Ireland that was completed Events – Our regular listing 8 at the start of this year (Generics bulletin,13January 2017, page 5). Accord was also given Price Watch UK – Our regular listing 10 the award for Patent Litigation of the Year for challenging Europeanpatent-protection for a People – GBMA seeks achief 32 high-concentration formulation of methotrexate, as well as winning the award for Business as Wood steps down Developmentofthe Year for developing lenalidomide tablets. Amneal picked up two awards –the Chartwell Pharmaceuticals-sponsored award for Company of theYear in the Americasregion and the Pharmacloud-backedaward for Leader of the Year, won by co-founders and co-chief executive officers Chintu and Chirag Patel – while Sandoz was recognised withboth the Regulatory Achievement of the Year award sponsored by Eignapharma, as well as with the Biosimilar Initiative of the Year award. Other awards See page 25 forcoverage of the event and winners sponsorsincluded Clarivate, Evapharma and International Health Partners, as well as mAbxience, Issue No.328 Panacea and Piramal. Next year, the Global Generics &Biosimilars Awards 2018–which are free to enter and attend –are due to take place on 9OctoberinMadrid, Spain. G Gen 3-11-17 Pg.1.indd 1 01/11/2017 17:35 COMPANY NEWS BUSINESSSTRATEGY MANUFACTURING Aristo buys Amneal Recipharm improves in Nordics and Spain serialisation abilities ermany’s Aristo Pharma has struck adeal to acquire Amneal ecipharm has enhanced the serialisation capabilities of its site in GNordics and Amneal Spain. Theagreement follows Strides Shasun’s RLisbon,Portugal, ahead of looming US and European enforcement acquisition of Amneal Australia through the Indian firm’s Arrow deadlines.Notingthatthe Lisbonfacilitywas itssixth site to “become Pharmaceuticals unit (Generics bulletin,8September 2017, page 3) serialisation-ready for the US and European markets”, the Swedish and comesasAmneal prepares to integrate with Impaxfollowing the contract developer and manufacturer said it had added an “additional pair’s agreementtomerge (Generics bulletin,20October 2017,page1). four packaging lines to the company’s current serialisation capabilities”. “The acquisition of Amneal Nordics will provide Aristo with an Afurther seven lines would be added to the facility by June 2018, ideal platform for expanding its business into the Nordic countries,” Recipharm noted. the German firm declared. It has renamed the unit –which has its In February2016, Recipharmunveiled athree-year plan to invest headquarters in Copenhagen, Denmark–asAristo Pharma Nordic. C40 million (US$47.1 million) in serialisation technology and processes “At the sametime,” Aristo stated,“the company is expanding the to comply with the EuropeanUnion’s Falsified Medicines Directive. Aristo Pharma Iberia business in Spain byabout40additional active At the time, Recipharm said it would be “ready for US serialisation from ingredients”with the acquisition of Madrid-based Amneal Spain. November 2017, in line with the US Drug Supply Chain Security Act”. Synergies from the dealwouldalso be evident for Aristo UK, the Earlierthisyear, however,the US Food and Drug Administration firmnoted, with the UK operation gaining 20 newproducts. “Inaddition, (FDA) issued draft guidance for industry stating that manufacturers the acquisition contains extensive dossier rights,” Aristo said,“which would not face action from the agency for failing to comply with ‘track include the right to expand into other countries.” and trace’ productidentifier and verifier requirements for an additional “Following the creation of Aristo Pharma Iberia in 2013 and year beyond the current guideline (Generics bulletin,14July 2017, Aristo UK in 2016, the acquisition of Amneal Nordics and Spain is a page 10).Due to industry-wide readiness concerns, the FDA delayed further step on Aristo’s journey to become amajor generics player proceedings by ayear, pushing back the action date to 27 November 2018. in Europe.” The German firm previously took over UK-based CEB Pharma (Generics bulletin,10March 2017, page 5). ‘Preparing for along time’ Formed in 2008, Berlin-based Aristo offers awide array of “Recipharmrecognised the complexity of implementing serialisation generics, mature brands and herbal remedies that it produces through a at avery early stage,” insisted Staffan Widengren, Recipharm’s network of facilities, located primarily in Germany. The group –which director for corporate projects, “and so we have been preparing for the also operates aMedinsa solid-dose plant in Madrid, Spain –has new regulations in the US and Europe for along time now.” This capabilities thatinclude semi-solids, liquids and oral cephalosporins. G included forming aglobal alliance to “introduce new serialisation capabilities” with Italianfirms Marchesini and SEA Vision, and US- IN BRIEF based TraceLink in mid-2016 (Generics bulletin,8July 2016, page 4), as well as delivering its first serialised batch to Saudi Arabia earlier PANACEA BIOTEC has received a certificate of good manufacturing this year (Generics bulletin,28April 2017, page 4). practice (GMP) compliance from Ukraine’s medicines agency for its Recipharm said it had “already delivered over 1.3 million serialised Indian oral solid-dosage manufacturing facilityand oncologysite in and aggregated packs to markets such as China, South Korea, Saudi Baddi, Himachal Pradesh, following June inspections. Noting that Arabia and Turkey, where serialisation regulations are currently in Ukrainewas amemberofthe PharmaceuticalInspection Co-operation place”. Widengren, who alsoleads the global steering committee for Scheme (PIC/S), Panacea said the registration of 22 products that Recipharm’s serialisation project, observed that the Lisbon facility received