Business

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.

Presenters during the 37th annual J.P. Morgan Healthcare Conference, held January 7-10 in San Francisco, California provided an overview about what potential investors can expect to see from their companies’ pharmaceutical pipelines over the next fiscal year.

During the second day of the 37th Annual J.P. Morgan Healthcare Conference, held January 7-10 in San Francisco, California, Dennis M. Lanfear, president and CEO of Coherus BioSciences, presented an overview of what he called his company’s “branded approach” to selling its newly launched biosimilar pegfilgrastim, Udenyca.

The fact that cost growth is driven largely by older products and not by new blockbuster therapies “is particularly important,” write the authors, “because in the current value-based landscape, increasing drug costs attributable to new products can sometimes be justified on the basis of improved outcomes. However, rising costs due to inflation do not reflect improved value for patients.”

During the first day of the 37th Annual J.P. Morgan Healthcare Conference, held January 7-10 in San Francisco, California, 2 major biosimilar developers gave a look at their strategies for 2019 and beyond.

Biosimilar developer Samsung Bioepis, a partnership between Samsung BioLogics and Biogen, has announced that it will partner with Chinese biopharmaceutical company 3SBio to develop and commercialize multiple biosimilars in mainland China.

This week, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance for industry on preparing for the growing likelihood that the United Kingdom will leave the European Union without a trade deal.

In October 2018, HHS Secretary Alex Azar proposed requiring drug companies to include the list price of a drug paid for by Medicare or Medicaid in direct-to-consumer (DTC) television advertising. Since the rule was announced, it has drawn feedback from stakeholders across the spectrum. The proposal, for which a comment period recently closed, received more than 140 comments on the Federal Register from payers, providers, patient advocacy groups, and others, varying in support of the proposal to raising concerns.

Coherus BioSciences has confirmed that it has launched its pegfilgrastim biosimilar, Udenyca, in the United States market.

The Center for Biosimilars® recaps the top news for the week of December 31, 2018.

After several pharmaceutical companies agreed to halt drug price increases in 2018 after receiving pressure from the Trump administration, the industry has kicked off 2019 with price increases on more than 250 prescription drugs.