• What Thailand Revealed About U.S. Pharma R&D
    What Thailand Revealed About U.S. Pharma R&D

    A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.

  • What To Know About Thailand’s Life Sciences Industry
    What To Know About Thailand’s Life Sciences Industry

    About a month ago, I was offered a tremendous opportunity: to attend a media trip to Thailand to learn about the country’s burgeoning life sciences industry. Like many people in the life sciences industry, I had no idea just how much has been going on within the country in terms of life sciences.

  • Political Uncertainty Emphasizes Need For More Efficient Biosimilar Development
    Political Uncertainty Emphasizes Need For More Efficient Biosimilar Development

    It’s unlikely biosimilar applications containing only analytical and preclinical data will meet the FDA’s demands for totality of the evidence within the next few years. However, a changing political climate urging quicker development and lower drug prices has only intensified the discussion within the biosimilar industry about developmental efficiency.

  • What Biosimilar Companies Should Think About A 70 % Discount
    What Biosimilar Companies Should Think About A 70 % Discount

    Edric Engert, managing director of Abraxeolus Consulting (formerly of Teva), shares his opinions on where the biosimilar market is heading, how we can promote greater uptake within the U.S., and just how “genericized” the market can and will potentially become.  

  • Samsung Bioepis: Turning “Lessons Learned” Into Biosimilars
    Samsung Bioepis: Turning “Lessons Learned” Into Biosimilars

    In the pharmaceutical industry, five years is a short length of time in which to launch a company, establish a development process, and bring several biosimilar candidates to market. In an interview, Paul Song shared some of the efforts Samsung Bioepis has made to pass down lessons learned and to continue evolving in the years ahead.

  • Behind Samsung Bioepis’ 5-Year Rise To Biosimilar Fame
    Behind Samsung Bioepis’ 5-Year Rise To Biosimilar Fame

    Samsung Bioepis celebrated its fifth anniversary in February 2017. I met with Paul Song, VP at Samsung Bioepis, to learn more about the company's motto, "Process innovation," which is credited for the company's swift rise to leadership in the European market.

  • 3 Notable Trends In Amgen’s 2017 Biosimilar Report
    3 Notable Trends In Amgen’s 2017 Biosimilar Report

    The 2017 Amgen "Trends in Biosimilars" report called attention to a few trends that align with what I’ve been observing within the industry that manufacturers, payers, and prescribers should expect for the year (and years) ahead.

  • Biosimilar Makers To Congress: Time To Act On REMS Legislation
    Biosimilar Makers To Congress: Time To Act On REMS Legislation

    REMS and voluntary restricted distribution programs have become a significant stumbling block for biosimilar companies. The Subcommittee on Health Care, Benefits, and Administrative Rules recently held a hearing on these controversial practices. If there was one big takeaway from the presenting witnesses, it’s that the biosimilars industry is ready for legislative action against these abuses.

  • 6 Predictions About Biosimilars In A Hospital Setting
    6 Predictions About Biosimilars In A Hospital Setting

    AmerisourceBergen's Dave Picard, VP of biosimilars and injectables, offers valuable insight into current market dynamics and how biosimilars will fit into current hospital distribution models.

  • IQPC Biosimilars Event Emphasizes Need For Regulatory Alignment
    IQPC Biosimilars Event Emphasizes Need For Regulatory Alignment

    I recently attended the IQPC Biosimilars Analytical Similarity, Clinical Studies, and Market Entry conference. This event, which took attendees into the heart of biosimilar development (the analytical and statistical work) was a great example of the scientific challenges developers may face while working with different regulatory agencies.

  • Should Your Biosimilar Really Be A Biobetter?
    Should Your Biosimilar Really Be A Biobetter?

    A few months ago, Eagle Pharmaceuticals agreed to acquire Arsia Therapeutics.This move will help Eagle partner with biosimilar companies to turn biosimilar candidates into biobetters. As Eagle CEO Scott Tarriff describes, the company’s business model of reformulating and improving existing small molecules is well-suited to the biologics space — especially considering his expectations of how the biosimilar space will play out.

  • 2017: A Standstill Year For Biosimilars?
    2017: A Standstill Year For Biosimilars?

    Despite the many positive steps we’ve taken to establish the biosimilar industry today, it seems as though the success of the biosimilar market in the U.S. is still looking hazy. Every conference I’ve gone to has focused on the challenges facing the industry and concerns over the different regulations being established. But CBI’s 12th Biosimilars Summit felt particularly realistic in how it approached those issues.

  • Celltrion: Data Transparency Imperative For Biosimilar Success
    Celltrion: Data Transparency Imperative For Biosimilar Success

    Over the past year, the biosimilar industry has developed two mantras: “education, education, education,” and “strategy, strategy, strategy.” But after my conversation with HoUng Kim, the head of the strategy and operations division for Celltrion Healthcare, I’d like to add another mantra to this list: “data, data, data.”

  • The Pure-Play’s Guide To Branding Biosimilars
    The Pure-Play’s Guide To Branding Biosimilars

    In the face of patient and physician hesitance about the safety and efficacy of biosimilars, long-known innovator company brands reassure stakeholders of the company’s experience, quality, and reliability. But this begs the question, how do smaller biosimilar companies fit in?

  • Why Real-World Evidence Will Challenge Biosimilars
    Why Real-World Evidence Will Challenge Biosimilars

    Though there is already a vast amount of available biosimilar-related real-world evidence (or Big Data), the industry will face quite a few pitfalls in securing and interpreting this data.

  • How To “Think Bigger” About Biosimilars
    How To “Think Bigger” About Biosimilars

    Real-world evidence, or data from real-world practice and use outside of clinical trials during drug development, is steadily becoming a key complement to randomized clinical trials. As Quintiles' Nancy Dreyer said, “So far, we’ve been concentrating on how biosimilars are made and how they will affect patients. But we need to be thinking bigger.”

  • Top 5 Biosimilar Developments Of 2016
    Top 5 Biosimilar Developments Of 2016

    In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.

  • What Biosimilars Need To Succeed In Clinical Practice
    What Biosimilars Need To Succeed In Clinical Practice

    A few weeks ago, I sat in on a webinar hosted by ProCE called “Biosimilars Out Of The Gate: What Are the Latest Developments?” Though the webinar was not directly targeting companies developing biosimilars, I felt some of the insights carried important implications for biosimilar makers.

  • Have Physician Attitudes Changed Toward Biosimilars In The Last Year?
    Have Physician Attitudes Changed Toward Biosimilars In The Last Year?

    In February 2016, InCrowd surveyed biologics-prescribing physicians in the U.S. to determine their views on prescribing biosimilars. In September 2016, InCrowd held a follow-up survey to determine how, or if, physicians’ thoughts had changed over six months. Some of the results might surprise you.

  • FDA Stresses Scientific Alignment, Not Harmonization For Global Biosimilars
    FDA Stresses Scientific Alignment, Not Harmonization For Global Biosimilars

    In most cases, the biosimilar guidelines put forth by all the major regulatory agencies are quite similar. But there are some differences that can challenge companies looking to have their biosimilars approved in these different countries. 

  • Simplifying Recombinant Protein Production
    Simplifying Recombinant Protein Production

    Biologic drugs have great promise, but they are complex and, as a result, are very expensive to manufacture and subject to technical pitfalls. 

  • The Many Gray Areas Of Biosimilar Commercialization
    The Many Gray Areas Of Biosimilar Commercialization

    Commercialization is one of the hottest topics of discussion in the biosimilar industry, perhaps because, so far, the path to commercial success is far from black and white.

  • Changes In Regulatory Requirements For Biosimilar Development In India
    Changes In Regulatory Requirements For Biosimilar Development In India

    In August 2016, India’s Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology revised the September 2012 Guideline for Similar Biologics. The revision was done to keep pace with ever changing global standards and to streamline the regulatory process for the authorization of biosimilars in India. What do biosimilar makers need to know?

  • How To Approach U.S. Physicians About Biosimilars
    How To Approach U.S. Physicians About Biosimilars

    As the U.S. faces its first biosimilars for oncology, rheumatology, dermatology, and gastroenterology indications, a new publication from the Biosimilars Forum shows there’s quite a bit of work to be done to educate U.S. physicians.

  • How These Biosimilar Unknowns Could Impact Manufacturers
    How These Biosimilar Unknowns Could Impact Manufacturers

    During my time covering biosimilars, I’ve grown well-versed in some of these arguments, including those around naming, labeling, and reimbursement. But several discussions in the past few months have added new layers of complexity to these issues.

  • What You Need To Know To Launch Biosimilars Globally
    What You Need To Know To Launch Biosimilars Globally

    In a biosimilar conference presentation, Suzette Kox of the International and Generic and Biosimilars Medicines Association laid out the unique regulatory frameworks in several countries, highlighting the challenges facing companies planning to launch products globally. 

  • 3 Big Biosimilar Questions At DIA 2016
    3 Big Biosimilar Questions At DIA 2016

    So far this year, I've attended three biosimilar conferences, the most recent being DIA Biosimilars 2016.  While all three events touched on the broad (and often political) biosimilar challenges, including reimbursement, naming, interchangeability, and patient access, DIA offered a special glimpse into the more nitty-gritty challenges of biosimilar development. 

  • For U.S. Biosimilar Success, Look Beyond Borders
    For U.S. Biosimilar Success, Look Beyond Borders

    In any industry, there are the experts who become known as the foremost voices of the industry. Biosimilar evangelist, Bert Liang, CEO of Pfenex and chair of the Biosimilars Council describes how far the U.S. biosimilar industry has progressed, as well as how far it has yet to go, offering biosimilar makers some important goals to strive for.

  • The Biosimilar Playbook: 4 Market Realities Manufacturers Must Know
    The Biosimilar Playbook: 4 Market Realities Manufacturers Must Know

    Throughout an expansive presentation about the biosimilar market’s progression, Sanford Bernstein analyst Ronny Gal homed in on four topics I think are important to reiterate.

  • How To Prepare Your Biosimilar Company For Interchangeability
    How To Prepare Your Biosimilar Company For Interchangeability

    While attending a recent biosimilars conference, I heard few clear opinions about whether interchangeability will be a beneficial strategy for biosimilar makers. However, in an interview, Pankaj Mohan, CEO of pure-play biosimilar company Oncobiologics, offered a very straight-forward perspective.

More From Biosimilar Development solution center