1. Jack Aurora, Chief Scientific Officer of Generic Drugs for Hisun Pharma, speaks toPharma IQ Editor Bryan Camoens on the emerging trends of biosimilars and thelegislation that comes with it. He also talks about biosimilars and pharmacovigilance andthe touches on the future of generic drugs and biosimilars.Bryan Camoens: What are some of the key challenges in marketing and distributinginnovators alongside generics in Asia?Jack Aurora:Focus on efficiencies and improved customer services are a few of the key drivers inmarketing and distribution in healthcare industry for both innovators and generics sectors.With the shift in margin compression, tougher and newer regulatory compliance andcompeting demand for capital have urged the desired and well needed focus on corecompetencies. In addition, the supply chain management has become more of aprofessional competency and necessity involving a strong link and provides a real timevisibility which is key strategic imperative.With an increase in the number of generics products and competing lower margins,sponsors are driven to offshore to better manage and improve the competitiveness andprofitability. This added logistics further complicates and make the distribution morechallenging and extremely difficult to manage. All these situations and challenges getdifficult to address and manage due to the high cost, time and internal political struggle.But at the end of the day, the industry has to come out and face the challenge by properoutsourcing with sound and effective risk mitigation and management policies.Bryan Camoens: With the emerging trend of biosimilars, how will the dynamics ofthe pharmaceutical market be affected?Jack Aurora: it is just not evenly distributed andproduce especially when referred to regulated markets in US and Europe. In todatough and difficult economic environment there are not too many players who can andare willing to jump into and embrace this challenge.
2. As of now some big players such as Sandoz, Teva, Pfizer, Hospira and Mylan do havesufficient funds and are not hesitating to invest in this area. With that in mind, the pool ofplayers in this area will remain small for a considerable span of time, say 10 years or so.are today. Biosimilars will be particularly popular among cancer and a few of otherin US. In this regard, after a decade long debate, biosimilars are finding a reality in theUS through a recent and an important milestone FDA meeting in Nov.2010 to allow drugmakers to weigh in on the regulations, including on such issues as interchangeabilitybetween biosimilars and their reference products.Even though the first milestone step has been taken successfully, the FDA must developthe working operational framework to implement the law and the same may take up to 3years followed by an extensive and well needed review process that will take another 2years or so and therefore Biosimilars may not appear under this new legislation until2015 the earliest but at least the clock has started moving. Legal concerns and difficultiesto market these Biosimilars (due to the reason that these are not interchangeable likegenerics) will be a few of other challenges to mention over here. With this backgroundand introduction, it is very difficult to paint the clear picture but it is quite certain that thepharmaceutical industry will continue to evolve and see tougher and tougher times ahead.Bryan Camoens What are the key market access barriers for generics within Asia?Jack Aurora: The ever changing dynamics of the generics market are driving strategic evolution ofleading players with portfolio management, geographic expansion and alliance networksdetermining success and failure. Maintaining breadth of portfolio and low cost supply iscritical for commodity generics players. Therefore, an effective portfolio management iscritical to future success in the generics market. In addition, generic players will have todeal with competition from within and without.In addition, one must manage within a world of price controls while keeping an eye onpatent violations, legal protections and expenses incurred. Finally it will be veryimportant and critical for the organizations to manage product pipeline very carefully andefficiently with proper risk assessment and management attributes in place.Bryan Camoens: What are the challenges and difficulties in marketing genericproducts in Asia?Jack Aurora:demand for Generics. As of now 25% of Asian population is above 55 years and thisexpanding population will further boost the demand for pharmaceutical drugs, and therelative affordability of generic pharmaceuticals in comparison to their branded drugsaugments their uptake. Majority of Asian countries has inadequate governmental
3. coverage for health insurance, a majority of the population is shouldering their burden ofhealthcare costs. In addition, rising cost of R&D due to increasing legislativerequirements and growing technological sophistications puts a lot of pressure in light ofsqueezing down profits due to governmental price controls and competition from outside.With all this background in place, the environment is becoming more complicated anduncertain. It is the cumulative outcome of combined political, economic, technologicaland social factors. Therefore the need of the hour is to be customer-led rather than beingproducer-driven. This will certainly demand innovations in each and every area ofpharmaceuticals starting from development until marketing. In parallel, efficiency,quality, and flexibility are other key focus areas to concentrate and develop so as tosurvive in business.Bryan Camoens: How do prescribers differentiate among the various genericoptions available in the market?Jack Aurora:Prescribers are the spokesperson and representatives of the patient, the end user of theproduct. Cost and quality image are the key drivers and will certainly remain the criticalin deciding for the preferred option. Recalls from the companies and critical observationsand warning letters from the regulatory bodies around the globe do play a significant rolein their decisions to pick up the appropriate generic.With that in prospective, the business is getting customer driven and focused on qualityand cost. Bringing in innovations in the product to satisfy the customer ease in handling,usage and managing the expectations with regard to the quality will become more andplayers will bring in their products in the market.Bryan Camoens: How unique is the positioning of generics companies in Asia andhow can they withstand competition from Big Pharma?Jack Aurora:biggest attraction of Asia. Generic companies in Asia are positioned very well and havevisible advantages with regard to productivity and cost structure advantages. With thisadvantage the Asian Pharma industry will continue to grow at an accelerated pace byseizing greater share of the fast growing global generics market.In addition, the industry is expected to significantly boost its share of the generics marketon the back of its expertise in research and development including process engineering.The focus should be from selling medicines to managing outcomes. Having said this, thegeneric industry should not stop here as the business is very dynamic and generics haveto be always on their toes to explore new ways to bring in innovations and furtherimprove their R&D cost and productivity. This is because
4. their efforts and are always changing and collaborating with inside and outer players andpartners to be able to respond to the demands from the different stakeholder communities. Bryan Camoens: Asias exports - what can companies do to ensure the quality andsafety of generics?Jack Aurora:Companies need to be aware of the latest changes in the regulatory world and alignthemselves to embrace and accept or even exceed those requirements. Qualitycommitment and focus should be a senior management core focus and top priority tomanage and address if required.The quality culture must percolate down the line and ongoing education, training andawareness programs must be in place to emphasis the importance and management keyfocus. Vendor qualification and vendor management program need to strengthened andstructured to bring in the focus on quality and customer satisfaction. Strong and effective eryimportant to deliver the right results and thereafter maintaining and improving the imageof the organization.Strict adherence to the regulatory requirements and any deviation and or non-compliancemust be thoroughly investigated and documented to ensure non-repeat incidence andstricter compliance in future. Last but not least, the supply chain process and participatingstake holders contributing to the movement of good, funds as well as information in thesupply chain should be coordinated and managed to ensure compliance and safety to theend customer.Bryan Camoens: With regards to biosimilars and pharmacovigilance, what are thekey considerations for companies and how can we overcome them?Jack Aurora:Pharmacovigilance has an entirely different meaning and scope with regard to biosimilarsas against conventional understanding while dealing with small molecules. This isbecause biosimilars cannot be authorized based on the same requirements that apply togeneric medicines.Despite the fact that the biosimilar and reference drug can show similar efficacy, thebiosimilar may exhibit different safety profile in terms of nature, seriousness or incidenceof adverse reactions. It should be kept in mind that due to their specific characteristics,pharmacovigilance activities required for biopharmaceuticals might differ from thoserequired for small molecules In addition, the data from pre-authorization clinical studiesnormally are insufficient to identify all potential differences.Therefore, clinical safety of similar biological products must be monitored closely on anongoing basis during the post-approval phase including continued risk benefit
5. assessment. The risk management plan for biosimilars should focus on heightens thepharmacovigilance measures, identify immunogenicity risk and implement special post-marketing surveillance. Pharmacovigilance activities can be either routine or additionalpost-authorization safety studies (PASS) activities. During safety assessment,stakeholders are encouraged to use knowledge obtained with biopharmaceuticals with acomparable pharmacology. PASS of biopharmaceuticals with a comparablepharmacology may therefore be used to complement each other.With the background and seriousness of the implications, the critical onus lies on pharmacompanies involved in research and manufacturing of Biosimilars. Since small changes inthe production and purification process might alter the safety profile and thereforeactivities to improve traceability of the specific biopharmaceutical responsible for theADR should be taken into account.The manufacturing process and controls must be strictly regulated and controlled. Anydeviations and changes should be properly assessed, authorized and documented in termsof risk assessment and follow-ups. The detailed and comprehensive risk managementplan and pharmacovigilance programs with its application, including a description of thepotential safety issues should be provided and communicated as required.Bryan Camoens: How will the generics industry continue to evolve with morepatents expiring in the next few years?Jack Aurora:There is a big opportunity knocking at the doors of generic industry but it is not that easyto grab the golden jackpot. Regulatory requirements and expectations are going up day byday and at the same time innovator and/or brand companies are getting more and morevigilant and bringing in strategies to delay the generics introduction in the market.Even generics (me too) companies will need to demonstrate that their products add valueto the patients. This will be accomplished by bringing in innovations into their functionsand focusing a quality culture from top to bottom of the organization.Quality by design (QbD) will be another requirement and need of the hour rather thanoption. So in nutshell generics industry will have a bright future ahead full ofopportunities but only the players with vigilant eyes to quickly read, understand andadapt to the changing business dynamics and focus on quality in-built rather than testingat the end will survive and dominate the pharma market.________________________________________________________________________Jack Aurora will be speaking at the Generics & Biosimilars Asia conference for moredetails please visit www.genericsbiosimilarsasia.com or drop an email firstname.lastname@example.org