Regulatory

Pfizer received authorization from the European Commission for its bevacizumab biosimilar, PF-06439535, to be sold under the trade name Zirabev for the treatment of certain advanced cancers: carcinoma of the colon or rectum, breast cancer, non–small cell lung cancer (NSCLC), renal cell cancer, and cervical cancer.

Health Canada has announced that all biologics, including biosimilars, will be identified by their brand names and nonproprietary names without the addition of a product-specific suffix. The regulator says that both the brand name and nonproprietary name of any biologic product should be used at all times so that products that share the same nonproprietary name can be differentiated by their brands.

The comment period has recently closed for the FDA’s proposed approach to the transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars, and among the comments from stakeholders is a suggestion that one drug maker may be interested in selling biosimilars of its own products.

The FDA released draft industry guidance for its pathway aimed at providing incentives to stimulate competition for branded drugs that have few or no generic counterparts in the marketplace. Separately, it also updated its “name and shame” list.

Even as developers begin work on the next wave of cost-saving biosimilars, and though approximately 50 biosimilar products (including monoclonal antibodies) have been approved in Russia to date, the country has not yet established clear regulatory guidelines for biosimilars.

The Center for Biosimilars® recaps the top news for the week of February 11, 2019.

The FDA this week announced draft guidance that would allow stakeholders to propose pharmaceutical quality standards for potential informal recognition to increase efficiency in drug development by achieving “voluntary consensus standards.”

The FDA recently released final guidance on the use of therapeutic proteins in developing biologics and biosimilars. "Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection" represents current FDA thinking about developing and validating assays for anti-drug antibody (ADA) detection.

The Center for Biosimilars® recaps the top news for the week of February 4, 2019.

This week, Senator Patrick Leahy, D-Vermont, reintroduced The Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act.

HHS Secretary Alex Azar offered a view of hope and optimism for the future of the American healthcare market in his remarks delivered as the closing keynote address at the Association for Accessible Medicine’s Access! 2019 meeting.

“Today’s healthcare system is unsustainable. [US] national health spending is expected to grow at 5.5% each year,” said Carol Lynch, president of Sandoz US and head of North America, setting the stage for a session at the Association for Accessible Medicine’s Access! 2019 meeting. “If all approved biosimilars had been marketed in a timely manner, Americans could have saved $4.5 billion.”

On Friday, Fresenius Kabi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for its MSB11022, a biosimilar adalimumab referencing Humira. The CHMP issued its opinions for the marketing of 2 brand names of the drug: Idacio and Kromeya.

As patients are being encouraged to self-manage disease and take an active role in their healthcare, communication with patients about the products that they use is becoming a hot topic among drug makers. During the second day of the Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, stakeholders gathered to discuss new directions in providing digital information to patients.

A recent white paper recaps the many barriers to biosimilar adoption in the United States and proposes a few ways that plans could change their reimbursement policies to help boost uptake.

Biosimilars are often described as lagging behind generic drugs because there are fewer in the market and they have lower acceptance and uptake. However, according to stakeholders who spoke during the second day of the Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, biosimilars are leading the way in the effort to create global comparator products for use in drug development.

The Center for Biosimilars® recaps the top news for the week of January 28, 2019.

Innovent Biologics, a China-based biopharmaceutical company, recently submitted a New Drug Application for its proposed bevacizumab biosimilar, IBI-305, referencing Avastin, to the Chinese regulatory agency, the National Medical Products Administration.

The House Committee on Oversight and Reform held its first hearing into drug prices this week and received testimony that pointed to increased biosimilar competition as a part of the solution to the problem.

A specific focus of the European Commission and European Parliament is to investigate the effect potential mergers and acquisitions (M&As) will have on the state of the market.

On the last day of the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, the head of the FDA practice at Avalere discussed her point of view that enabling a global reference product for biosimilars would provide global access for patients.

The Center for Biosimilars® recaps the top news for the week of January 21, 2019.

Sandoz’s biosimilar etanercept, Erelzi, referencing the brand-name Enbrel, has been granted an indication for the treatment of psoriatic arthritis by Health Canada.

The European Union has announced that The Committee of the Permanent Representatives of the Governments of the Member States to the European Union (Coreper) agreed this week on the European Council’s draft regulation that grants an exception to Supplementary Protection Certificates (SPCs).

Closed-door sessions began last month on possible patent law reform in 2019 in the United States.

The FDA has approved Samsung Bioepis’ Ontruzant (trastuzumab-dttb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer and HER2 overexpressing gastric cancer.

The Center for Biosimilars® recaps the top news for the week of January 14, 2019.

A new paper, published this week in Current Medical Research and Opinion, seeks to clarify the US definition of interchangeability and differentiate it from the separate concepts of automatic substitution and physician-mediated switching.

After the UK Parliament voted to reject Prime Minister Theresa May’s proposed Brexit deal with just weeks to go before the United Kingdom’s planned withdrawal from the European Union, the pharmaceutical industry has warned that a no-deal Brexit poses “tangible and immediate threats” to patient safety and public health.

When the shutdown ends, said Scott Lassman, JD, partner at Goodwin, “It’s not going to be like flipping a switch…this is going to have longer-term consequences.”