Development

In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gives his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.

Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the second day of the FDA’s development workshop that clinical outcomes will not be affected.

Sarfaraz K. Niazi, PhD, reacts to CMS' list of the first 10 drugs chosen for price negotiation under the Inflation Reduction Act (IRA), including 3 biologics with no biosimilar competition.

The FDA approved its first biosimilar indicated for multiple sclerosis (MS), Sandoz’ Tyruko (natalizumab-sztn), a biosimilar referencing Tysabi (natalizumab).

Biosimilar teriparatide improves bone mineral density (BMD) when patients with osteoporosis are treated for a year or more.

Sarfaraz K. Niazi, PhD, recapped his answers to a recent interview where he discussed his predictions on the future of the biosimilar industry in the United States.

Streamlining biosimilar development would permit biosimilar development of more and a wider variety of biological drugs, fast-tracking biosimilar development without impacting patient safety or effectiveness, according to an opinion piece.

Sarfaraz K. Niazi, PhD, gives an overview of the global biosimilar landscape, noting why some countries have biosimilars, including follow-on biologics and unbranded biologics, for certain products and why others do not.

Despite global sales for Amjevita (adalimumab-atto) growing by 29% year-over-year and the agent being the first adalimumab biosimilar on the US market, sales in the United States dropped 63% from the first quarter to the second quarter of 2023.

Reference bevacizumab and proposed biosimilar (BAT1706) demonstrate high similarity to each other.

Sarfaraz K. Niazi, PhD, details his efforts to encourage congressional leaders to draft legislation that would remove interchangeability requirements and animal toxicology studies for biosimilars.

Kashiv Biosciences announced positive phase 1 results for its omalizumab biosimilar; Dongkook Pharmaceutical shared the launch of an insulin glargine biosimilar (Glargia); and Quebec, a province in Canada, said it’s adding a ranibizumab biosimilar (Byooviz) to its reimbursement list.

Sarfaraz K. Niazi, PhD, flagged an upcoming FDA meeting where stakeholders can make public comment on whether clinical efficacy testing for biosimilars is necessary for regulatory approval.

The Center for Biosimilars® provides an updated look on the adalimumab biosimilars that are coming down the US pipeline as well as what stakeholders need to know and how they can prepare ahead of the US launch of 8 adalimumab biosimilars in July 2023.

In his latest column, Sarfaraz K. Niazi, PhD, takes a look at common misconceptions about biosimilar development and expresses how companies can seize new opportunities to save the US biosimilar market and generate profit.

The ranibizumab biosimilar XSB-001 (Ximluci) demonstrated biosimilarity to the originator (Lucentis) in a phase 3 trial in neovascular age-related macular degeneration (nAMD).

Sarfaraz K. Niazi, PhD, examined the new FDA guideline that acts as an invitation to biosimilar developers to decrease the cost of testing, potentially opening the door for companies to reduce nonclinical testing of biosimilars entirely.

In his latest column, Sarfaraz K. Niazi, PhD, went over some best practices for implementing innovative solutions for the purposes of streamlining biosimilar development.

Authors of a new in vitro study said Sanofi’s biosimilar SAR341402, approved in June 2020 by the European Medicines Agency for use in insulin pumps, had similar stability compared with the originator under stress conditions in their experiments.

Although the FDA has consistently edited its testing guidelines for biosimilar developers over the years, clinical testing is still very expensive and time-consuming. Sarfaraz K. Niazi, PhD, offers the FDA and companies a plan of action for reducing clinical testing expenses for biosimilar products.

A phase 1 clinical trial in China comparing the tocilizumab biosimilar candidate LZM008 to the reference product (Actemra) found pharmacokinetic (PK) parameters within the bioequivalence margins and similar immunogenicity and safety in healthy participants.

The authors of what they say is the largest and longest follow-up study comparing the trastuzumab biosimilar SB3 to the reference product (Herceptin) in HER2-positive breast cancer found “no clinically meaningful difference” between the biosimilar and the reference product.

At the 2023 Association for Research in Vision and Ophthalmology Annual Meeting, Samsung Bioepis shared comparable safety, efficacy, and immunogenicity data through 1 year between its aflibercept biosimilar (SB15) and the originator (Eylea).

Sarfaraz K. Niazi, PhD, dives into how pharmacodynamic (PD) markers may be better than clinical efficacy testing for predicting whether a biosimilar is equally as safe and effective as its reference product, in his latest column.

A long-term follow-up of a phase 3 study comparing ranibizumab biosimilar SB11 to the reference product (Lucentis) in neovascular age-related macular degeneration (nAMD) found the similarity in efficacy end points reported early on was maintained through 52 weeks.

The misconceptions about disposable bioreactors' lifecycle are gone; the era of hard-piped, giant, stainless-steel tanks for biosimilar development is history now, according to Sarfaraz K. Niazi, PhD, in his latest column.

Celltrion Healthcare shared data from a phase 3 clinical trial confirming that its omalizumab biosimilar had comparable safety and efficacy to the reference product (Xolair).

Sarfaraz K. Niazi, PhD, explains and analyzes the FDA's changes for the Biosimilar User Fee Act (BsUFA) meetings and how they influence the efficiency of the biosimilar approval process in the latest installment of his bimonthly column.

In the wake of adalimumab biosimilars hitting the US market, Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health, hyped up the current biosimilar market trends and the other products coming down the pipeline during her talk at the Festival of Biologics.

At the Festival of Biologics, Hillel Cohen, the executive director of scientific affairs at Sandoz, shared the current body of literature on biosimilar-to-biosimilar switching, saying that although there isn’t much published data, the vast real-world experience demonstrates the safety of this type of medication switch.