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Coherus BioSciences announced on Friday that it has become the latest biosimilar developer to settle with AbbVie, maker of the brand-name adalimumab, Humira, over a proposed biosimilar. In an intellectual property twist, Coherus also announced that it has sued a rival biosimilar developer, Amgen.

Bio-Thera Solutions, a China-based biosimilar developer, announced that it has dosed the first patients in its phase 3 clinical study of BAT1806, a proposed biosimilar tocilizumab referencing Actemra, an interleukin-6 inhibitor.

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

A new report from research institution NORC at the University of Chicago finds that hospitals and health systems face high annual growth in drug spending, and some of the highest-spend drugs are those facing biosimilar challenges.

Drug makers often point to substantial research and development (R&D) costs as reasons for the high prices of innovator drugs, particularly in oncology. However, some stakeholders have expressed skepticism about whether R&D costs are indeed in line with the prices that drug makers charge. In a new study published in JAMA, investigators sought to compare sales of cancer drugs with estimated R&D costs.

A South Korean court ruled this week that penalties imposed against Samsung BioLogics, parent company of biosimilar developer Samsung Bioepis, by the Financial Services Commission (FSC) for allegedly committing fraud have been suspended.

Amgen and Allergan today announced positive topline results of a combined phase 1 and phase 3 study evaluating ABP 798, a proposed biosimilar rituximab, in comparison with the reference Rituxan in patients with rheumatoid arthritis.

Despite the challenges inherent in biosimilars, they have a fairly high probability of success, said Edric Engert, managing director of Abraxeolus Consulting, in a presentation at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.

Drug maker Alvotech announced this week that it has raised $300 million, through a private bond offering, that it will used to continue its growth, refinance debt, and further develop its biosimilar pipeline.

Last week, CMS unveiled new, voluntary changes for Medicare Part D. The new 5-year model, which CMS calls Part D Payment Modernization, will test the feasibility of shifting more risk to Medicare Advantage and Part D plans.

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

In 2018, Green Shield Canada launched its pilot Biosimilar Transition Program, through 3 plan sponsors, under which patients already receiving biologics were switched to biosimilars. Now that the pilot is complete, the payer is calling the program a success.

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).

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.

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.”

Bio-Thera announced yesterday that it has partnered with Cipla Limited in a licensing agreement for its potential bevacizumab biosimilar, BAT1706, referenced on Avastin.

A representative from Pfizer confirmed to The Center for Biosimilars® that the company has terminated 5 of its preclinical biosimilar programs after the results of the company’s annual investment review.

Last week, Senator Bernie Sanders, I-Vermont, and Representative Elijah Cummings, D-Maryland, introduced legislation comprising 3 bills to curb the cost of prescription drugs.

During this year’s investment symposium, held in San Francisco, California, from January 7-10, biosimilars featured prominently in drug makers’ and regulators’ visions for 2019 and beyond. Here are 7 key takeaways from the conference’s biosimilars presentations.

Republic of Korea-based biosimilar developer Alteogen has reported that it has been granted a process patent for its method of producing an aflibercept biosimilar, ALT-L9, referencing Regeneron’s innovator drug Eylea.

Eculizumab must be administered every 2 weeks, versus every 8 weeks for the newly approved ravulizumab. Another possible advantage for Alexion is that the newer drug also has the benefit of new patent exclusivities that could help Alexion stave off the impact of competition from oncoming eculizumab biosimilars.

Biosimilar developer Celltrion has seen strong success with its biosimilar infliximab, CT-P13, which is marketed in the United States as Inflectra and in other territories as Remsima. This week, the company said that its product has captured 56% of the infliximab market in Europe as of the third quarter of 2018.

Civica Rx, the nonprofit generic drug company formed last year by 5 health systems in order to combat drug shortages and high prices for generic drugs, added 12 additional health systems this week, bringing the total to 750 hospitals in the United States joining the venture so far.

The Center for Biosimilars® recaps the top news for the week of January 7, 2019.

Following promises of halts to increases in drug prices in 2018, pharmaceutical makers began January by raising the prices of more than 250 drugs. Now, HHS Secretary Alex Azar is calling on companies to bring their list prices back down.

During the 37th annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California, drug makers Mylan and Momenta explained the role that biosimilars will play in their growth, while AbbVie outlined its strategy for managing direct biosimilar competition.

During the 37th annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California, FDA Commissioner Scott Gottlieb, MD, delivered a keynote address encompassing his goals for the direction of the FDA in the coming year.

The second day of the 37th Annual J.P. Morgan Healthcare Conference saw presentations from drug makers Amgen and Sanofi—both of whom produce both innovator products facing biosimilar competition as well as biosimilars of competitors’ products—as well as from Alexion, which is defending its flagship product from advancing biosimilar challengers.