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My Journey with Biosimilars in APAC

September 21st, 2016 - 0 Comments

The year 2012 witnessed an extensive focus on biosimilars, irrespective of the size and geographic presence of pharmaceutical companies. It was evident that the world was getting ready for low cost biologics. This was regarded as an immediate alternative to sustain budget cuts on healthcare owing to austere measures.

However, the development of biosimilars was not as easy as anticipated despite the emergence of cutting-edge innovations in biotechnology. Numerous issues surfaced, threatening the very development of biosimilars. Quality issues aside, microheterogeneity, immunogenicity, and interchangeability issues led to a serious debate on regulatory aspects, ultimately leading to stringent guidelines governing the approval.

My interaction with various stakeholders at  some of the conferences I attended in the APAC helped in understanding their concerns on biosimilar purity and expectations for future products. Some of the key points covered during the conferences are highlighted below.

BIT’s 7th Annual International Congress of Antibodies-April 2015, Nanjing, China 

In the early 2015, pharmaceutical companies across APAC were very focused on developmental aspects of a biosimilar. The topics discussed in the conference belong to Breaking Research of Antibodies and their technology platforms, Antibody-Drug Conjugates, Bispecific and Multispecific Antibodies as well as Antibody Structure Prediction and Antibody Design.

phamax made a presentation on The quest of biosimilar mAbs to gain stakeholders’ acceptance – The rocky road ahead”.

During the panel discussion, it was agreed that the following factors would play a key role in obtaining high quality biosimilars:

  1. Bioanalytical Strategies for Supporting Biosimilars
  2. Regulatory Challenges and Opportunities
  3. Assay Development for Immunogenicity and PK of Antibody Biosimilars

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Biosimilars APAC summit October 2015, Singapore

The key topics covered during the conference include Regulatory Developments & Country Updates, Clinical Development, Launching & Commercializing Biosimilars in Asia. During the presentation I discussed “Effective Market Access Strategies in APAC to Realize Complete Potential of Biosimilars” and I conducted a workshop on “Biosimilars Interchangeability and Similarity”.

The workshop gives an overview on recent developments on legislations and health policies on biosimilar interchangeability globally with a key focus on APAC. It is crucial to assess the role of stakeholders and their awareness leading to a paradigm shift in perception towards affordable, yet effective treatment options. Also, a company has to understand the treatment pathways for the indications approved for biosimilars (focusing on biosimilar mAbs) and map critical leverage points translating into potential segments for biosimilar uptake.

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Early Market Access for Biosimilars: AIN Medicare, Kelantan, Aug 2016, Malaysia

A workshop was conducted on “Need for Early Market Access Strategies for Effective Commercialization of Biosimilars” to communicate the need for early market access strategies. Issues related to early access and pricing, Quality and interchangeability, investment and partnership models were discussed. The main emphasis of this event was to:

  1. Leverage the current regulatory scenario in the APAC region and focus on biosimilar market
  2. Evaluate the opportunities for licensing
  3. Understand the significance of the key parameters in market access framework

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Since the approval of the first biosimilar and development of specific guidelines and pathways, particularly in the APAC region, the emergence of clinical and non-clinical stakeholders influencing the uptake of the product demands have tailored market access strategies. The pharmaceutical companies in APAC are currently focusing on commercialization aspect having overcome technological hindrances and developmental hurdles. Now that pharmaceutical companies have sensed the importance of customized market access, they will incorporate the market access strategies right from the early stages of the product development life-cycle.

Source of the featured image: http://globalbiodefense.com

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