News

As medicines become more numerous and often more expensive, healthcare professionals seek new ways to understand which treatments are most likely to yield the best outcomes at sustainable costs.

Results of a phase 3 trial of IBI303, a proposed adalimumab biosimilar referencing Humira, showed that it is therapeutically equivalent in terms of efficacy, safety, and immunogenicity to the originator product, according to a study published in the first issue of The Lancet Rheumatology.

In the oncology realm, August 2019’s biggest business development was the forward momentum of Amgen’s 2 newly debuted oncology biosimilars, and perhaps the biggest news in the biosimilar space from the inflammatory disease perspective also involved Amgen and its involvement in a long-running patent dispute.

The Center for Biosimilars® recaps the top stories for the week of August 26, 2019.

Treating macular edema associated with central retinal vein occlusion (CRVO) with aflibercept was noninferior to ranibizumab treatment at 100 weeks, while the results for bevacizumab versus ranibizumab were inconclusive.

Drug maker Henlius Biotech is recruiting patients for a single-center, open-label, dose-escalation phase 1 clinical trial that will evaluate the safety and tolerability of combination therapy with a biosimilar bevacizumab and an anti–programmed cell death protein 1 (PD-1) antibody in patients with advanced solid tumors.

Amgen, maker of the brand-name pegfilgrastim (Neulasta), and Mylan, which partnered with Biocon to develop a biosimilar (Fulphila), have entered a joint status report in the District Court for the Western District of Pennsylvania.

Editorial board member Brian Lehman, MBA, MHA, RPh, examines current progress and challenges that biosimilars face in the US context, and argues that stakeholders have the opportunity to be part of the solution to high drug prices by supporting biosimilars.

This week saw a pair of developments for patients with neuromyelitis optica spectrum disorder (NMOSD), a rare, severe, relapsing, neuroinflammatory autoimmune disease that can be fatal.

A new paper published this month may help to allay some concerns that US providers may have about using FDA-approved biosimilar rituximab.

In a filing with the US Securities and Exchange Commission this month, Silicon Valley-based biotech company Revance Therapeutics said that it has entered into an amendment to a Collaboration and License Agreement with Mylan; the amendment extends the period of time Mylan has to decide whether to continue to develop and commercialize a biosimilar of Allergan’s onabotulinumtoxinA (Botox).

Women are more likely than men not to take their diabetes medication as prescribed in an effort to control prescription drug costs, as are adults under age 65, according to a report published this month by the Centers for Disease Control and Prevention (CDC).

A Japanese postmarketing surveillance study of biosimilar infliximab CT-P13 (Inflectra, Remsima) concludes that the biosimilar and its reference, Remicade, are comparable in terms of efficacy and adverse drug reactions in patients with inflammatory bowel disease (IBD) and that the biosimilar is a cost-efficient option that is interchangeable with the reference in real-world practice.

Amgen announced yesterday that it will acquire apremilast (Otezla) from Celgene. The small-molecule drug, which inhibits phosphodiesterase 4, specific for cyclic adenosine monophosphate, is an orally administered therapy for patients with psoriatic arthritis and patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Early dose reductions in the adjuvant chemotherapy combination of 5-fluorouracil, epirubicin, cyclophosphamide, and docetaxel negatively impacted survival rates for patients with intermediate- or high-risk breast cancer.

Administering the brand-name pegfilgrastim (Neulasta) via an on-body injection device (sold as Onpro) carries some risk of device failure, resulting in a missed or partial dose of pegfilgrastim. A recent cost simulation found that, when taking this failure into account, assured prophylaxis with biosimilar filgrastim offers the greatest cost efficiency.

A more compelling rationale for switching medications—particularly in light of “marginal” cost savings provided by biosimilars in the United States—is necessary, says the guideline.

The International Coalition of Medicines Regulatory Authorities, an executive-level coalition of regulators from 29 medicines regulatory authorities from territories including Australia, Brazil, Canada, China, the European Union, and the United States, among others, recently released a statement of confidence in biosimilars.

In 2018, Dr. Reddy’s indicated that it expected to initiate clinical studies for the bevacizumab biosimilar to facilitate EU and US regulatory approval, but this week, a company representative told The Center for Biosimilars® in an email that, “currently, we are gearing up for filings in emerging markets for Versavo.”

A new report from Matrix Global Advisors and the National Business Group on Health, sponsored by Boehringer Ingelheim, shows that employers could see substantial savings from biosimilars, but those savings won’t come without a concerted effort to encourage biosimilar use.

“These results will fully usher the treatment of chronic lymphocytic leukemia [CLL] into a new era,” said Tait Shanafelt, MD, professor of medicine at Stanford. “It seems likely that, in the future, these patients will be able to forego chemotherapy altogether.”

The study in patients with non-Hodgkin lymphoma (NHL) is the second of a pair of studies intended to facilitate regulatory submissions for the proposed biosimilar.

The Center for Biosimilars® recaps the top stories for the week of August 19, 2019.

When Samsung Bioepis’ trastuzumab biosimilar, SB3 (Ontruzant), gained regulatory approval in multiple highly regulated markets, it did so on the strength of a data package including evidence from a phase 3 study in patients with HER2-positive early breast cancer. Later, it became apparent that some of the patients who received the reference product in the phase 3 study had been exposed to lots of Herceptin with a marked shift in relative antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

A recent study suggests that adding rituximab to a high‐dose methotrexate‐based combination chemotherapy could prolong overall survival as well as progression-free survival for patients with primary central nervous system lymphoma, a rare and aggressive form of lymphoma.

Biocon has gained a certificate of good manufacturing practice (GMP) from the European Medicines Agency’s Irish inspection authority for its Malaysian manufacturing site where it produces its insulin glargine biosimilar, Semglee, referencing Lantus.

Along with innovations in design comes the question of patients’ willingness to pay for features that differentiate self-injection devices from one another.

A recent study found that rituximab maintenance therapy provides no additional benefit for patients with diffuse large B‐cell lymphoma (DLBCL) who are in complete remission after receiving rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy.

This week, researchers reported updated results from a post hoc subgroup analysis from the adjuvant period of treatment in the biosimilar’s phase 3 trial; these results, say the authors, demonstrate that the biosimilar, used in the adjuvant setting, has comparable efficacy and safety to the reference at 1 year.

Fewer than one-third of patients newly diagnosed with rheumatoid arthritis (RA) used anti–tumor necrosis factors agents, other biologics, Janus kinase inhibitors, or conventional disease-modifying antirheumatic drugs in 2014.