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European Biopharmaceutical Review

Need for Speed

The barriers to biosimilar development, approval and adoption are being overcome. New regulations in the biopharmaceutical industry, together with technological innovations, have resulted in the rapid growth of the biosimilar market, which is projected to exceed $19.5 billion by 2022 (1). The top 10 best-selling products account for 37.6% of the total biologic market value, which is estimated to represent $53.4 billion in global sales (2). These products are protected by patents that are due to expire in the next couple of years, opening the way for biosimilar development.

Biosimilars are not a perfect copy of the original molecule, differentiating them from small molecule generics. They are usually developed using reverse engineering technology based on the innovator biological product, which, in theory, is anticipated to reduce both the time and cost of development (3). However, in practice, there are often significant differences between the manufacturing processes used to produce the biosimilar, compared with the originator. These may include the use of varying cell lines, as well as altered upstream and downstream manufacturing processes. Such changes can affect the biochemical structure of the biosimilar with unknown immunogenic response to the patient.

To demonstrate that the biosimilar has equal potency, safety and efficacy, compared to the innovator biological product, clinical trials and post-marketing pharmacovigilance need to be provided in support of the regulatory dossier to obtain marketing authorisation.

Effective Management

Despite lower development costs, the considerable investment needed in manufacturing biosimilars accounts for a modest 10-30% in savings when compared to those of the innovator biological product (4). It is estimated that the market price for a biosimilar will be between 65-85% of the original innovator drug (5). Given the low cost savings, the high development cost and low price expectations to gain an attractive return on investment, it is essential to identify savings opportunities during biosimilar development. These will likely come from effective clinical trial programmes that will translate into chances to reduce the time taken for market entry.

Critical aspects of clinical trial effectiveness for biosimilars are the same as those that apply to innovative biological products: robust and flexible study design, patient recruitment, knowledgeable sponsors and investigator teams, and efficient management of trial supply operations. Experience shows that a flexible and well-designed supply chain can provide the necessary support to implement an aggressive enrolment of patients and accommodate study changes. This may include the introduction of new study sites around the world, or support with study design such as randomisation and blinding that can help sponsors and CROs achieve their goals successfully and in a timely manner.

Effective management of logistics and operations for clinical trial supplies can make a significant difference in saving time and money during the development of new biosimilar compounds. This goes beyond delivering the right supplies to the patient, but also includes verification of good manufacturing processes for products released into the EU, correct storage conditions, labelling, packaging and distribution without temperature excursions, and timely arrival to clinical study sites. Partnering with the right clinical supply service can provide a competitive advantage to the biosimilar pharma company. In particular, clinical supply chain management can contribute to making the biosimilar market more cost-effective.

Teamwork


Cross-functional teams that are involved in the management of clinical supplies, from the moment the business is won until the job is finalised, can follow the client and maintain a constantly committed relationship long after the contract is completed. It is advisable to look for this when choosing a clinical supply vendor.

The formation of teams around a highly skilled and experienced project manager can help identify opportunities for time reduction and material wastage by polishing project execution every step of the way. When these changes are implemented with full knowledge and participation of all team members, the results are a more effective clinical supply organisation. Additionally, recognising potential problems ahead of time can translate into invaluable time and money savings to the client.

Montitoring Budgets

Keeping costs under control is very important; as clinical trials globalise, distribution costs can rise exponentially. In order to minimise the uncertainty within logistics budgets, a clinical supply vendor can provide valuable advice on the economic impact of different logistics strategies. For example, stocking strategies in central hubs, depots and clinical sites can be designed for the timely shipping of supplies in a ‘little and often’ approach. However, this can result in higher shipping costs. It is important to discuss this upfront with the clinical supply partner to allow for more efficient planning.

Upfront Planning

Biosimilar manufacturing chains can be complex, involving different partners with licensing deals and technology transfer requirements. To decrease risk and shorten development timelines, sponsors are designing three-arm studies using comparator products from different lots and regions such as the US and the EU. When planning trials in the EU, products must be verified by an EU qualified person (QP) before they can be released, which has the potential to delay clinical study timelines. Therefore, having the advice of a QP early in the process to build the biosimilar development and release roadmap will allow a clear understanding of the steps to follow long before the activity is part of the critical chain.

Sourcing Reference Material


As part of the clinical study design for safety and efficacy testing, the innovator biological product needs to be used as a comparator. Since a biosimilar version of a drug can be developed simultaneously by different companies, comparator products can be difficult to obtain. Therefore, partnering with a clinical supply business that has established relationships with multiple wholesalers in different countries and markets will be highly advantageous. It can provide guidance on import/export requirements of the comparator source and the market, and advise on the cost implications of sourcing a comparator from different regions according to price, resulting in extra savings.

Flexible Packaging Activities

The past year alone has seen a 20% increase in the number of biosimilars in clinical trials, with many of these coming from the same innovator biological products, making the enrolment of patients competitive and difficult. There are two strategies a clinical supply partner can offer to minimise time expenditure due to changes in study protocol during packaging of supplies:

Flexibility
To recruit patients, a clinical trial may need to involve several different countries. Furthermore, the country selection may need to be changed depending on patient availability, potentially involving countries that were previously not described in the original clinical protocol. A partner that is flexible and can quickly accommodate these alterations can become a real asset – for example, by introducing multilingual options for labels and booklets, expenses can be saved should the country destination change.

Just-in-Time Labelling
A clinical supply partner can also provide just-in-time labelling of supplies through which countryspecific labels are only applied after distribution orders are received for shipments to clinical sites. This can be executed as a discreet operation in a packaging suite or may be integrated into the whole distribution process.

Refrigerated Labelling Capacity

Biological comparator products generally need to remain at refridgerated temperatures throughout the entire chain of custody, including packaging operations. Most vendors have limited refridgerated packaging capacity, much of which is already committed to strategic partners. Flexible solutions, such as the use of cold plate technology, are used by some vendors to rapidly increase cold chain capacity and shorten timelines at times of peak demand. It is important for the biopharma company to take this into account when looking for their clinical supply partner, making sure response times can be built into the service agreement to guarantee on-time and on-specification delivery of supplies.

Cold Chain Expertise

Both the cold chain expertise and record of the clinical supply partner need to be verified in order to avoid the negative consequences of temperature excursions during shipment. These could result in costly delays of product to market, loss of patient enrolment in a trial and loss of product.

When selecting a partner, it is important to consider the following: the range of shipping solutions offered; any additional validated shipment temperature testing methods; the number and expertise of people involved in the supply chain; any solutions provided to permanently avoid deviations from specified temperature ranges in future shipments; and the management of third-party relationships.

Taking the Opportunity

Biosimilars have the potential to provide patients with the ability to access high-quality medicines to treat conditions such as cancer, diabetes and arthritis at lower cost than the current leading biological drug. However, balancing low development and high manufacturing costs means that savings are only 10-30%, compared to those of the innovator biological product. Therefore, it is imperative to identify every opportunity during development to reduce time to market.

References

1. Visit: www.pharmatimes.com/ Article/15-01/global_biosimilars_ pipeline_expands_40_in_12_ months_study
2. Bruno CF and Martinez JL, Biosimilars: Company strategies to capture value from the biologics market, Pharmaceuticals 5: pp1,393-1,408, 2012
3. Visit: www.gabionline.net/sponsoredarticles/ biosimilar-monoclonalantibodies- development-simplified
4. Walsh G, Biopharmaceutical benchmarks 2010, Nature Biotechnology 28(9): pp917-924, 2010
5. Moran N, Fractured European market undermines biosimilar launches, Nature Biotechnology 26: pp5-6, 2008


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Martin Lamb has worked in the clinical trial supplies industry since 1996. Prior to joining Biotec Services International as Commercial Director in 2014, he spent more than 17 years with Almac Clinical Services. Martin’s previous publications include papers on patient compliance in clinical trials, novel blinding technologies and global clinical trial logistics. He studied Pharmacology at the University of Leeds, and obtained postgraduate qualifications in Marketing.

Claudia Williams
has worked in the pharma industry since 2010. She has over 10 years’ experience as a Research Scientist, and recently acquired an MBA with a marketing focus from Cardiff University. Prior to joining Biotec Services International as a Business Development Assistant/Marketing Assistant in 2014, she spent three years with Novartis Canada. Claudia has also worked as a scientist at Oregon State University and the University of California Davis in the US. She studied for her PhD in Toxicology at Oregon State University and for her MSc in Mexico.
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