The Top 5 Biosimilars Articles for the Week of July 9

The Center for Biosimilars® recaps the top 5 articles for the week of July 9, 2018.


Hi, I’m Samantha DiGrande for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilars articles for the week of July 9.

Number 5: The FDA released a draft guidance document to address changes to the Biosimilar User Fee Amendments II and provide an explanation about the new fee structure as well as the types of fees entities are responsible to pay.

Number 4: A recent analysis by consumer website GoodRx concluded that the price people pay for generic drugs at the pharmacy varies greatly based on where they live.

Number 3: Greek researchers found that a considerable number of rheumatoid arthritis patients are not achieving low disease activity despite receiving established recommendations for RA therapy.

Number 2: A survey of German patients who used a prefilled pen for subcutaneous delivery of biosimilar etanercept SB4 has reported a very high level of patient satisfaction with the product.

Number 1: The FDA recently issued a 32-page Form 483 to Mylan after a 5-week inspection of its manufacturing plant in Morgantown, West Viriginia.

Finally, last week, our e-newsletter asked whether you think that the FDA’s list of off-patent, off-exclusivity drugs without generic competitors will help to foster competition for biologics as well.

To view results of the poll, visit us on LinkedIn.

To read all of these articles and more, visit

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