cocktail reception & awards presentation · year. as co-host, iqvia has shown huge support for...

Recognising the best in the globalgenerics and biosimilars industries

Tuesday 9 October 2018Palacio Municipal de Congresos

Madrid, Spain

Presented by

In association with

Nominations

Cocktail Reception & Awards Presentation

GGB18 Nominations Cover.indd 1 14/08/2018 09:45

GENERICS bulletinS2 21 September 2018

Global Generics & Biosimilars AWARDS 2018

Recognising the best in the global generics and biosimilars industries

Presented by Generics bulletin in association with IQVIA

Judges consider 2018 Award Nominations Nominations for the 13 prestigious Awards that make up the Global

Generics & Biosimilars Awards 2018 are listed in this special supplement. Expert Judges have assessed over 100 entries for the Global Generics & Biosimilars Awards 2018, to create the shortlist of Award finalists.

A wide variety of disciplines in the generics and biosimilars industries are covered by the 13 Awards, including acquisitions, leadership, product innovation, litigation, business developments and other industry achievements. Companies are also able to enter for company of the year and regional companies of the year.

Winners of the 13 categories (listed to right) will receive their Awards during a cocktail reception at the Palacio Municipal de Congresos, Madrid, Spain on 9 October. The reception will be co-hosted by Generics bulletin and IQVIA. Angela Lamont, British television and conference presenter, will bestow Awards on worthy winners. Attendees will also be able to network with colleagues in the global generics and biosimilars industries.

We are pleased to welcome back many Award sponsors for another year. As co-host, IQVIA has shown huge support for the Awards and will be presenting API Supplier of the Year and Company of the Year.

Sanaclis will be sponsoring the Award for Biosimilar Initiative of the Year. West Pharma will for the first time be sponsoring the Award for Business Development of the Year, with Pharmacloud returning to present Leader of the Year. Acquisition of the Year is sponsored and presented by Pharmawise, along with returning sponsor Panacea presenting the Award for Company of the Year, EMEA. Piramal will be sponsoring the Award for Innovation of the Year. And mAbxience is sponsoring the Award for Regulatory Achievement of the Year. The Awards welcome new sponsor Teva TAPI to present Industry Partner of the Year, as well as Masters Speciality Pharma to hand out accolade for Company of the Year, Americas. Charity International Health Partners (IHP) is once more presenting the Award for Corporate Social Responsibility (CSR) Initiative of the Year.

Tickets and tables are available on a ‘first come, first served’ basis and space is limited, so make sure you request your complimentary ticket today or book a table to avoid disappointment. Gn [email protected]

Awards will be presented in the following order:

n Corporate Social Responsibility (CSR) Initiative of the Year Sponsored by IHP

n Industry Partner of the Year Sponsored by Teva TAPI

n Regulatory Achievement of the Year Sponsored by mAbxience

n Biosimilar Initiative of the Year Sponsored by Sanaclis

n API Supplier of the Year Sponsored by IQVIA

n Business Development of the Year Sponsored by West Pharma

n Innovation of the Year Sponsored by Piramal

n Leader of the Year Sponsored by Pharmacloud

n Acquisition of the Year Sponsored by Pharmawise

n Company of the Year, Americas Sponsored by Masters

n Company of the Year, Asia-Pacific Sponsored by Generics bulletin

n Company of the Year, EMEA Sponsored by Panacea

n Company of the Year Sponsored by IQVIA

GENERICS bulletin S321 September 2018


Company of the Year

Company of the Year, Asia-Pacific

Sponsored by

Company of the Year, Americasn AmnealAmneal is an integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The firm has around 6,500 employees in its operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the US. Amneal is one of the fastest growing generic pharmaceutical manufacturers in the US.

n LannettLannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic products for a wide range of medical indications. During the third quarter of 2017, Lannett acquired five products from UCB and entered into three new agreements with strategic alliance partners, which have progressed and already created new revenue streams to further build the product offering.

n MylanMylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, the company innovates to satisfy unmet needs. Mylan offers a portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend.

n PfizerPfizer is a US pharmaceutical corporation headquartered in New York City, with its research headquarters in Connecticut. Pfizer reported solid second-quarter 2018 financial results, with total company revenues up 2% operationally, driven by the continued growth of key brands such as Eliquis, Ibrance and Xeljanz, as well as biosimilars and emerging markets.

Sponsored by

n Beximco PharmaSince being the first Bangladeshi pharma company to receive US Food and Drug Administration (FDA) approval in 2015, the firm has began export to an additional 10 countries since 2016. Beximco continues to focus on growing its US portfolio with the firm receiving its fourth US (FDA) approval and commencing export of its third product to the US. Beximco recently acquired a majority stake in Nuvista Pharma.

n GlenmarkGlobal generics are already the mainstay of Glenmark’s business and will be so for the foreseeable future. Specialty will help the firm move up the value chain to brand-name products in highly-regulated markets, a lucrative opportunity that will unlock a new, sustainable revenue stream. Innovative products show promise to not only act as game-changers from a business perspective but also improve the lives of countless patients.

n Intas/AccordIntas is a global pharmaceutical formulation development, manufacturing and marketing firm headquartered in India. Intas’ success and growth lies in clinical execution of successful moves made in the areas of manufacturing, R&D, biotechnology and global operations over three decades. As of 31st of March 2015, Intas has recorded a turnover of ~Rs.51.5 billion at 21% CAGR over the last 5 years and a profit growth of ~50% CAGR.

n Shanghai Henlius BiotechShanghai Henlius Biotech specialises in the discovery, development, manufacturing and commercialisation of high-quality biosimilar, bio-better and novel mAbs for oncologic and auto-immune disorders. Henlius pipeline includes 11 product candidates with 17 successful IND filings and 13 approvals from CFDA. Its first product HLX01 is potentially the first approved biosimilar in China.

Sponsored by

n Accord HealthcareAccord Healthcare continues to go from strength to strength. It demonstrates commitment to patients resulting in it becoming a top 10 generics and biosimilar company in Europe. Accord is also on track to break into the top 5 by 2021 with a strong specialty products portfolio. It has also been listed as the fasted growing generics and biosimilar company in the world.

n HikmaHikma was founded 40 years ago in Jordan, and in 2005 was listed on the London Stock Exchange. The company has grown at a considerable pace, both organically and through acquisition. The acquisition strategy meant that legacy corporate brands remained, and accordingly, so did many micro- cultures, messages, systems and processes. In 2018, Hikma felt the time was right to refresh the brand and modernise the look and feel.

n StadaIn less than a year, Stada has launched and completed numerous initiatives to make the firm more efficient and successful. In the first quarter of 2018 both generics and branded products contributed to higher adjusted group sales. The management negotiated various acquisition and co-operation contracts to facilitate faster expansion and internationalization of the product portfolio.

n CinnaGenCinnaGen is the only biopharmaceutical company in Iran that has active and under-negotiation technology-transfer projects. In 2017, CinnaGen was selected as the exporter of the year. The value of exports was more than US$46.8 million that showed 97% growth in comparison to 2016. The products of CinnaGen are exported to countries such as Iraq, Russia and Syria.



Company of the Year, EMEA

Sponsored by

n AlvogenAlvogen is a global company focused on developing, manufacturing and selling generic, brand, over-the counter and biosimilar products. The firm has commercial operations in 35 countries with 2,800 employees and operates five manufacturing and development hubs in the US, Romania, Korea and Taiwan. Alvogen’s leadership team is dedicated to fostering a dynamic change-driven culture committed to meeting the needs of customers.

n CinnaGenCinnaGen is the only biopharmaceutical company in Iran that has active and under-negotiation technology-transfer projects. In 2017, CinnaGen was selected as the exporter of the year. The value of exports was more than US$46.8 million that showed a 97% growth in comparison to 2016. The products of CinnaGen are exported to countries such as Iraq, Russia and Syria.

n HikmaHikma was founded 40 years ago in Jordan, and in 2005 was listed on the London Stock Exchange. The company has grown at a considerable pace, both organically and through acquisition. The acquisition strategy meant that legacy corporate brands remained, and accordingly, so did many micro-cultures, messages, systems and processes. In 2018, Hikma felt the time was right to refresh the brand and modernise the look and feel.

n StadaIn less than a year, Stada has launched and completed numerous initiatives to make the firm more efficient and successful. In the first quarter of 2018 both generics and branded products contributed to higher adjusted group sales. The management negotiated various acquisition and co-operation contracts to facilitate faster expansion and internationalization of the product portfolio.

n Laurus LabsHaving established itself as a global leader in tackling HIV, Laurus Labs has devoted huge amounts of energy and expertise to combating Hepatitis C where it is most needed. Hepatitis C is considered a silent menace, caused by the Hepatitis C Virus (HCV), resulting in inflammation of the liver. It is recognised as a major public health problem worldwide, responsible for chronic liver disease and a variety of extra-hepatic manifestations.

n Piramal EnterprisesPiramal assists partners in developing cost-effective medicines supplied timely to reduce the burden of disease. Piramal aims to be ‘the’ benchmark of customer delight. This is achieved through adding differentiating factors across various customer interactions and services – a highly relevant and attractive API portfolio, impeccable quality standards and compliance records, innovative and efficient R&D, and delivery excellence.

n ScinoPharmScinoPharm Taiwan. is a leading process R&D and API manufacturer. With research and manufacturing facilities in both Taiwan and China, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early-phase pharmaceutical activities for brand companies and APIs for the generic industry. The firm is also expanding into the field of sterile oncology injectable formulations.

n Teva TAPITAPI is a market leader in the API field and the authority in the market when it comes to expertise, developing new processes and techniques, and providing an exceptional customers service to support customers with every need. It’s part of TAPI’s agenda and main goal to put customers in the centre of everything they do. When customers work with them, they know they will receive a high-quality product and support.

Sponsored by

n Accord HealthcareAccord recently achieved a milestone by being the first to gain a CHMP positive opinion for its second-generation modified-release filgrastim, Pelgraz. The recombinant protein is an essential tool for treating a serious side effect of chemotherapy – neutropenia. Neutropenia is one of the most common reasons for reductions or delays in chemotherapy schedules, which impairs survival outcomes and quality of life for patients.

n MylanThrough a partnership with Biocon, commercialisation experience and scientific research expertise, Mylan was able to obtain regulatory ap-proval for Semglee. Over the past year, Mylan received first-in-class FDA approvals for Ogivri (trastuzumab-dkst), a biosimilar to Herceptin, and Fulphila (pegfilgrastim-jmdb), a biosimilar to Neulasta, and reached several additional regulatory milestones.

n SandozIn January 2018, Sandoz announced a first-of-a-kind global partnership with Biocon, to drive the early-stage pipeline for immunology and oncol-ogy biosimilars. This partnership aims to develop, manufacture and commercialise biosimilars. It equips both global players to increase patient access to high-quality, affordable biologics in the future and further strengthens their portfolio to stay competitive in this growing market.

n Shanghai Henlius BiotechIn April 2015, Henlius obtained clinical trial approval and initiated its Phase III study recently, becoming the first enterprise in China launching Phase III clinical trial for treatment of RA using rituximab injection. In October 2017, Henlius submitted its first new drug application (NDA) for HLX01 to the CFDA, which assigned HLX01 into its priority evaluation list in early 2018, making HLX01 potentially the first approved biosimilar in China.

Biosimilar Initiative of the Year

Sponsored by

API Supplier of the Year



Leader of the Year

Sponsored by

n AlvogenAlvogen’s growth in revenues and profitability has been outstanding under the leadership of Robert Wessman, CEO. Last year, Alvogen posted global revenues exceeding US$1bn for the first time, while sister company, Alvotech, is in a great position to take advantage of the market shift towards biosimilars. Thanks to a well-targeted portfolio for the US and Central and Eastern (CEE) markets, Alvogen has been able to make a mark in the industry.

n IntasIntas has grown from a small single-site company in India into a global leader in pharmaceuticals – 15,000 employees, 85 countries, 14 manufacturing sites and US$1.7bn in revenues. Binish Chudgar, the vice chairman of Intas, has guided this 30-year transformation. The business today reflects his singular vision, his values and his drive. He has personally designed every aspect of the company’s successful strategy.

n mAbxienceEmmanuelle Lepine, general manager, has 20 years of experience in the pharmaceutical and biotechnology industry. Emmanuelle is a recognised leader, with hands on experience in establishing and leading successful firms. Emmanuelle has been supporting organisations to develop, register and launch products on international markets. Emmanuelle achieved measured and sustainable growth with an improved performance.

n StadaIn less than a year, Claudio Albrecht has launched and completed numerous initiatives to make Stada more efficient and successful. In the first quarter of 2018 both generics and branded products contributed to higher group sales. He and his team negotiated various acquisitions and contracts to increase expansion and internationalization of the product portfolio. Albrecht has contributed to a change of the corporate culture.

Acquisition of the Yearn AlvogenIn August 2017 Alvogen signed a definitive agreement to acquire Omega Bittner, a Russia-based pharmaceutical firm owned by Perrigo Company. Working with well-established and recognised brands in Russia, the firm focuses on a targeted portfolio of over-the-counter drugs in categories such as women’s healthcare and cough & cold. This acquisition supports their strategy to gain more exposure to Russia’s high growth market.

n AmnealAmneal Pharmaceuticals and Impax Laboratories announced in May 2015 that they completed their business combination to form Amneal Pharmaceuticals. Amneal is now the 5th largest generics business in the US, with a growing, high-margin specialty franchise. The firm expects to generate annual double-digit growth in net revenue, adjusted EBITDA and adjusted EPS over the next three years.

n AurobindoIn 2017 Aurobindo signed a definitive agreement to acquire from Apotex International, its commercial operations and certain supporting infrastructure in five European countries – Poland, Czech Republic, the Netherlands, Spain and Belgium.The acquisition will accelerate Aurob-indo’s European growth strategy, by strengthening its geographic reach and commercial infrastructure, particularly in Eastern Europe.

n Beximco PharmaTo strengthen its global presence as a generic pharmaceutical company, Beximco Pharma entered into a non-binding MOU in October 2017 to acquire a majority shareholding (85.23%) in Nuvista Pharma, a leading Bangladeshi pharma company specialising in hormones and steroid drugs. In April 2018, the acquisition of a majority stake in Nuvista was completed.

Sponsored by

n Lambda Therapeutic ResearchLambda is one of the forerunners in the Indian CRO industry. Incepted in 1999, Lambda is proud to be associated with leading companies in the generic and biotechnology industries. It has a global bed strength of >700 beds across its clinical facilities in Ahmedabad and Mumbai in India and Toronto, Canada. Lambda is the CRO of choice for many sponsors looking to conduct complicated, challenging trials.

n RephineRephine’s slogan “Quality Matters” has shown its legitimacy in outstanding achievements in the last year, working alongside generics and biosimilars manufacturers and suppliers. It continues to pursue the aim to become the consultancy of choice for quality matters in manufacturing and the results are outstanding. Rephine has maintained excellent GMP, GCP and regulatory services while launching RephineSourcing.com, a new API sourcing portal.

n Piramal EnterprisesAn ‘innovation driven, customer focused’ global leader that assists partners in developing cost-effective medicines. Piramal Pharma Solutions is leading the way in pharmaceutical development and manufacturing, with a large portfolio of APIs, intermediates & formulations. Piramal entered the generic API business in 1995 with a focus on becoming the preferred partner in providing a wide range of quality APIs to its customers.

n Masters Speciality PharmaMasters Speciality Pharma is a UK-headquartered global pharma company, with subsidiaries in El Salvador, Brazil, India and the US. Masters has a mission to provide access to high-quality medicines for all, by prioritising emerging markets. Since 1984, it has remained committed to its vision: Medicines Reaching Further and used it as a guiding mantra for providing greater access to medicines in the emerging markets.

Industry Partner of the Year

Sponsored by



n Cinfa BiotechCinfa developed a biosimilar using an innovative, efficient development approach, based on factual scientific and regulatory considerations. The approach was accepted by the EMA for ongoing MAA review. Cinfa Biotech is close to success, its first biosimilar developed in just four years, could be one of the first pegfilgrastim biosimilars to receive regulatory approval in Europe. Approval for B12019 is expected in 2018.

n Intas PharmaceuticalsIntas has successfully prepared and filed a “non-generic” dossier for a fixed-dose combination of olmesartan/amlodipine/HCTZ, containing the same forms and strengths as Sevikar HCT. Intas’ dossier is the result of a thoughtful analysis, smart regulatory strategy, and co-ordinated action plan, which has involved a cross-departmental expert team of R&D, IP, clinical and regulatory.

n mAbxiencemAbxience’s mission is to deliver solutions and bring hope to as many people as possible worldwide through our biosimilars, as well as contribute to the sustainability of healthcare systems worldwide. mAbxience has a strategic plan for regulatory submissions, focusing first on Latin America and Rest of World, and continuing with Europe Union, America and Japan.

n MylanMylan has received FDA approvals for Ogivri (trastuzumab-dkst), a biosimilar to Herceptin, and Fulphila (pegfilgrastim-jmdb), a biosimilar to Neulasta, and reached several additional regulatory milestones for these products worldwide. Mylan is the only firm today with two FDA-approved biosimilar products supporting cancer patients. Through a global partnership with Biocon, Mylan gained regulatory approval for Semglee in Europe and Australia.

Regulatory Achievement of the Year

Sponsored by

n IntasIn recent years, following its strong commitment to R&D and determination to improve people’s health and well-being, Intas has created a new Innovation Business Unit. Headquartered in Barcelona, Spain, it has the aim of building up a differentiated and innovative portfolio. This includes innovative pharmaceutical forms, new fixed dose combinations, and additional strengths, among others.

n Chemo GroupChemo vaginal ring is a new innovative contraceptive ring with new benefits for its users. It represents an excellent example of industrialization from development to manufacturing in the shortest time, and with an optimized process and the best and latest technology. The aim for was for this to become the first generic vaginal ring in the market – for it to have the best technology as well as increased benefits for users.

n Accord HealthcareOne of Accord’s aims is to contribute and improve patients and caregivers’ conditions. Methotrexate Accord falls within this aim. Methotrexate Accord has been developed to deliver benefits to patients affected by rheumatoid arthritis and other chronic conditions that are struggling with dexterity challenges. This innovative development proves that Accord has put investment and efforts in pathological states.

n SandozSandoz Canada is the first Canadian pharma company to enter the medical cannabis field. Sandoz announced a collaboration agreement with Tilray, a Health Canada licensed producer of medical cannabis. It will provide patients with treatment options, with stringent manufacturing standards that are adapted for medical conditions, advocating for broader access to products and increasing innovation, research and education.

Innovation of the Year

Sponsored by

n IntasIntas aims to provide high quality service and knowledge in the most accessible way. The company has developed two very dynamic, innovative and user-friendly ways of presenting its dossier portfolio; The Intas ePortfolio, through the website, and via the Intas apps available in the app stores of Android and IOS platforms.

n HikmaTo coincide with Hikma’s 40th anniversary, the company felt the time was right to refresh the brand and modernise the look and feel, and to tell its story in the most impactful way. The rebranding objectives were to build internal unity and reduce the complexities created by multiple corporate brands and improve clarity, consistency and impact of messages.

n mAbxiencemAbxience, part of the Insud Pharma Group, and Amneal Pharmaceuticals have signed an exclusive licensing and supply agreement in the US for mAbxience’s bevacizumab, a biosimilar candidate for Avastin. Under the milestone-based commercial agreement, mAbxience will lead product, clinical development and subsequent manufacture while Amneal will guide the product through regulatory approval.

n StadaStada has entered into a co-development agreement with Swedish biotech company Xbrane on a biosimilar of Xlucane. It is a biosimilar to the VEGFa inhibitor ranibizumab. Lucentis is used in treatment of several eye diseases. Due to the lower costs compared to the originator product, Xlucane could help many people all over the world to improve their lives.

Business Development of the Year

Sponsored by

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Corporate Social Responsibility (CSR) of the Year

EXPERT JUDGES


n AccordAccord believes in ensuring patients gain access to quality and affordable medicines. As part of its international CSR programmes it has already doubled its donations by providing 1,008,883 treatments in 2018 and has committed to supporting more initiatives to help even more vulnerable people in need of medical treatment throughout the world.

n AlvogenIn 2017 and entering into 2018, Alvogen’s CSR programs have grown considerably and the company has been able to touch more lives than ever before. This has been done across a wide range of CSR initiatives, aided by a greater number of Alvogen employees taking part in dona-tions and personal involvement.

n Dr Reddy’sThrough its initiative – Community Health Intervention Program – Dr Reddy’s has been able to provide primary, promotive and preventive care, to a large segment of the rural population. The School Improvement Program (SIP) covers 130 government schools, impacting 49,150 students from two states, Telangana and Andhra. The program is designed to help government schools in various academic and non-academic aspects.

n SandozNovartis Access, a global access-to-medicines program launched in late 2015 and operated by Sandoz, is now up and running in six countries. As of 2018, Novartis Social Business is also now responsible for the entire Novartis offering in seven countries – a major step towards the program’s goal of maximizing patient reach across all income levels to ensure a sustainable long-term business.

Sponsored by


We wish each nominee the very best of luck, and look forward to seeing you all at the event.

Join the journey at iqvia.com/successCopyright © 2018 IQVIA. All rights reserved.

IQVIA IS PROUD TO CO-HOST THE GENERICS BULLETIN AWARDS.

cocktail reception & awards presentation · year. as co-host, iqvia has shown huge support for...

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